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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00304031
Other study ID # RTOG-0525
Secondary ID CDR0000465183EOR
Status Completed
Phase Phase 3
First received
Last updated
Start date January 2006
Est. completion date December 2016

Study information

Verified date May 2020
Source Radiation Therapy Oncology Group
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with temozolomide may kill more tumor cells. It is not yet known which schedule of temozolomide when given together with radiation therapy is more effective in treating glioblastoma or gliosarcoma.

PURPOSE: This randomized phase III trial is studying two different schedules of temozolomide to compare how well they work when given together with radiation therapy in treating patients with newly diagnosed glioblastoma or gliosarcoma.


Description:

OBJECTIVES:

Primary

- Determine if dose-intensifying (increasing the "dose-density") the adjuvant temozolomide component of the chemoradiation treatment enhances treatment efficacy as measured by overall survival of patients with newly diagnosed glioblastoma or gliosarcoma.

Secondary

- Determine if dose-intensifying the adjuvant temozolomide component of the chemoradiation treatment enhances treatment efficacy as measured by progression-free survival.

- Determine in patients with unmethylated MGMT (O-6-methylguanine-DNA methyltransferase) if dose-intensifying the adjuvant temozolomide component of the chemoradiation treatment enhances treatment efficacy (overall and progression-free survival) compared with patients receiving conventional temozolomide dosing.

- Determine in patients with methylated MGMT if dose-intensifying the adjuvant temozolomide component of the chemoradiation treatment enhances treatment efficacy (overall and progression-free survival) compared with patients receiving conventional temozolomide dosing.

- Determine if there is an association between tumor MGMT gene methylation status and treatment response.

- Compare and record the toxicities of the conventional and dose-intense chemotherapy regimens.

- Evaluate whether 6-month progression-free survival is associated with overall survival.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to recursive partitioning analysis class (III vs IV vs V), MGMT gene methylation status (methylated vs nonmethylated vs indeterminate), and radiotherapy criteria used (standard vs revised European).

After completion of study treatment, patients are followed every 3 months for 1 year, every 4 months for 2 years, and then every 6 months thereafter.


Recruitment information / eligibility

Status Completed
Enrollment 1173
Est. completion date December 2016
Est. primary completion date February 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years to 120 Years
Eligibility Inclusion criteria:

1. Histopathologically proven diagnosis of glioblastoma. Since gliosarcoma is a variant of glioblastoma, gliosarcoma is also an eligible diagnosis.

2. Patients must have at least 1 block of tissue available for analysis of MGMT status; fresh frozen tumor tissue acquisition is encouraged.

3. Diagnosis must be established by open biopsy or tumor resection. Patients who have only had a stereotactic biopsy are not eligible.

4. The tumor must have a supratentorial component.

5. Patients must have recovered from the effects of surgery, postoperative infection, and other complications before study registration.

6. A diagnostic contrast-enhanced magnetic resonance imaging (MRI) or computerized tomography (CT) scan (if MRI is not available) of the brain must be performed preoperatively and postoperatively. The postoperative scan must be done within 28 days of registration and prior to the initiation of radiotherapy. Preoperative and postoperative scans must be the same type. If CT scans were performed perioperatively, a CT and an MRI should be performed before randomization.

6.1. Patients unable to undergo MRI imaging because of non-compatible devices can be enrolled, provided pre- and post-operative contrast-enhanced CT scans are obtained and are of sufficient quality.

7. Therapy must begin = 5 weeks after the most recent brain tumor surgery.

8. History/physical examination within 14 days prior to study registration.

9. Neurologic examination within 14 days prior to study registration.

10. Documentation of steroid doses within 14 days prior to study registration and stable or decreasing steroid dose within 5 days prior to registration.

11. Karnofsky performance status of = 60.

12. Age = 18 years.

13. Complete blood count (CBC)/differential obtained within 14 days prior to study registration, with adequate bone marrow function as defined below: 13.1 Absolute neutrophil count (ANC) = 1500 cells/mm3. 13.2 Platelets = 100,000 cells/mm3. 13.3 Hemoglobin = 10 g/dl. (Note: The use of transfusion or other intervention to achieve Hgb = 10 g/dl is acceptable.)

14. Adequate renal function, as defined below:

14.1 Blood urea nitrogen (BUN) = 25 mg/dl within 14 days prior to study registration 14.2 Creatinine = 1.7 mg/dl within 14 days prior to study registration

15. Adequate hepatic function, as defined below:

15.1 Bilirubin = 2.0 mg/dl within 14 days prior to study registration 15.2 Alanine aminotransferase (ALT) = 3 x normal range within 14 days prior to study registration 15.3 Aspartate aminotransferase (AST) = 3 x normal range within 14 days prior to study registration

16. Patients must sign a study-specific informed consent prior to study registration.

If the patient's mental status precludes his/her giving informed consent, written informed consent may be given by the responsible family member.

17. For females of child-bearing potential, negative serum pregnancy test within 72 hours prior to starting temozolomide.

18. Women of childbearing potential and male participants must practice adequate

Exclusion criteria:

1. Prior invasive malignancy (except for non-melanomatous skin cancer) unless disease free for = 3 years. (For example, carcinoma in situ of the breast, oral cavity, and cervix are all permissible).

2. Recurrent or multifocal malignant gliomas

3. Metastases detected below the tentorium or beyond the cranial vault.

4. Prior chemotherapy or radiosensitizers for cancers of the head and neck region; note that prior chemotherapy for a different cancer is allowable. Prior use of Gliadel wafers or any other intratumoral or intracavitary treatment are not permitted. See Section 1.

5. Prior radiotherapy to the head or neck (except for T1 glottic cancer), resulting in overlap of radiation fields.

6. Severe, active co-morbidity, defined as follows:

- 6.1. Unstable angina and/or congestive heart failure requiring hospitalization.

- 6.2. Transmural myocardial infarction within the last 6 months.

- 6.3. Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration.

- 6.4. Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration.

- 6.5. Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol.

- 6.6. Acquired Immune Deficiency Syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive.

- 6.7. Major medical illnesses or psychiatric impairments that in the investigator's opinion will prevent administration or completion of protocol therapy.

- 6.8. Active connective tissue disorders, such as lupus or scleroderma, that in the opinion of the treating physician may put the patient at high risk for radiation toxicity.

7. Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.

8. Pregnant or lactating women, due to possible adverse effects on the developing fetus or infant due to study drug;

9. Prior allergic reaction to temozolomide.

10. Patients treated on any other therapeutic clinical protocols within 30 days prior to study entry or during participation in the study.

11. No tissue provided for histopathologic central review and MGMT status.

12. Tissue provided by stereotactic biopsy method.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Concurrent temozolomide
Daily oral temozolomide (75 mg/m2) up to 49 doses.
Radiation:
Concurrent radiation therapy
60 Gy in 2 Gy fractions
Drug:
100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle
Oral temozolomide on days 1-5 of a 28-day cycle. Dose starts at 150mg/m2 for first cycle, increases to 200mg/m2 for subsequent cycles if no unacceptable toxicity. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with responding disease may receive up to 6 more courses of temozolomide.
75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle
Oral temozolomide on days 1-21 of a 28-day cycle. Dose starts at 75mg/m2 for first cycle, increases to 100mg/m2 for subsequent cycles if no unacceptable toxicity. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with responding disease may receive up to 6 more courses of temozolomide.

Locations

Country Name City State
Canada Tom Baker Cancer Centre - Calgary Calgary Alberta
Canada Margaret and Charles Juravinski Cancer Centre Hamilton Ontario
Canada McGill Cancer Centre at McGill University Montreal Quebec
Canada Ottawa Hospital Regional Cancer Centre - General Campus Ottawa Ontario
Canada Centre Hospitalier Universitaire de Quebec Quebec City Quebec
Canada Allan Blair Cancer Centre at Pasqua Hospital Regina Saskatchewan
Canada Saint John Regional Hospital Saint John New Brunswick
Canada Cancer Care Program at Thunder Bay Regional Health Sciences Thunder Bay Ontario
Canada Princess Margaret Hospital Toronto Ontario
Canada CancerCare Manitoba Winnipeg Manitoba
United States Rosenfeld Cancer Center at Abington Memorial Hospital Abington Pennsylvania
United States Hickman Cancer Center at Bixby Medical Center Adrian Michigan
United States McDowell Cancer Center at Akron General Medical Center Akron Ohio
United States Summa Center for Cancer Care at Akron City Hospital Akron Ohio
United States Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest Allentown Pennsylvania
United States American Fork Hospital American Fork Utah
United States McFarland Clinic, PC Ames Iowa
United States AnMed Cancer Center Anderson South Carolina
United States CCOP - Michigan Cancer Research Consortium Ann Arbor Michigan
United States Saint Joseph Mercy Cancer Center Ann Arbor Michigan
United States DeCesaris Cancer Institute at Anne Arundel Medical Center Annapolis Maryland
United States Theda Care Cancer Institute Appleton Wisconsin
United States Northwest Community Hospital Arlington Heights Illinois
United States Mission Hospitals - Memorial Campus Asheville North Carolina
United States Piedmont Hospital Atlanta Georgia
United States Auburn Radiation Oncology Auburn California
United States Rush-Copley Cancer Care Center Aurora Illinois
United States St. Agnes Hospital Cancer Center Baltimore Maryland
United States Mary Rutan Hospital Bellefontaine Ohio
United States St. Joseph Cancer Center Bellingham Washington
United States MeritCare Bemidji Bemidji Minnesota
United States Billings Clinic - Downtown Billings Montana
United States CCOP - Montana Cancer Consortium Billings Montana
United States Hematology-Oncology Centers of the Northern Rockies - Billings Billings Montana
United States Northern Rockies Radiation Oncology Center Billings Montana
United States St. Vincent Healthcare Cancer Care Services Billings Montana
United States St. Joseph Medical Center Bloomington Illinois
United States Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - Main Campus Boca Raton Florida
United States Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center Boise Idaho
United States Wood County Oncology Center Bowling Green Ohio
United States New York Methodist Hospital Brooklyn New York
United States Bryn Mawr Hospital Bryn Mawr Pennsylvania
United States Providence Saint Joseph Medical Center - Burbank Burbank California
United States Fletcher Allen Health Care - University Health Center Campus Burlington Vermont
United States Fairview Ridges Hospital Burnsville Minnesota
United States St. James Healthcare Cancer Care Butte Montana
United States Radiation Oncology Centers - Cameron Park Cameron Park California
United States Aultman Cancer Center at Aultman Hospital Canton Ohio
United States Graham Hospital Canton Illinois
United States Mercy Cancer Center at Mercy San Juan Medical Center Carmichael California
United States Memorial Hospital Carthage Illinois
United States Sandra L. Maxwell Cancer Center Cedar City Utah
United States Cancer Center of Kansas, PA - Chanute Chanute Kansas
United States Hollings Cancer Center at Medical University of South Carolina Charleston South Carolina
United States John H. Stroger, Jr. Hospital of Cook County Chicago Illinois
United States University of Chicago Cancer Research Center Chicago Illinois
United States Adena Regional Medical Center Chillicothe Ohio
United States Cleveland Clinic Cancer Center at Fairview Hospital Cleveland Ohio
United States Cleveland Clinic Taussig Cancer Center Cleveland Ohio
United States Penrose Cancer Center at Penrose Hospital Colorado Springs Colorado
United States CCOP - Columbus Columbus Ohio
United States Doctors Hospital at Ohio Health Columbus Ohio
United States Grant Medical Center Cancer Care Columbus Ohio
United States John B. Amos Cancer Center Columbus Georgia
United States Mount Carmel Health - West Hospital Columbus Ohio
United States Riverside Methodist Hospital Cancer Care Columbus Ohio
United States Dartmouth - Hitchcock Concord Concord New Hampshire
United States Mercy and Unity Cancer Center at Mercy Hospital Coon Rapids Minnesota
United States Medical City Dallas Hospital Dallas Texas
United States Texas Oncology, PA at Texas Cancer Center Dallas Southwest Dallas Texas
United States Geisinger Cancer Institute at Geisinger Health Danville Pennsylvania
United States Oakwood Cancer Center at Oakwood Hospital and Medical Center Dearborn Michigan
United States Grady Memorial Hospital Delaware Ohio
United States CCOP - Iowa Oncology Research Association Des Moines Iowa
United States John Stoddard Cancer Center at Iowa Lutheran Hospital Des Moines Iowa
United States John Stoddard Cancer Center at Iowa Methodist Medical Center Des Moines Iowa
United States Medical Oncology and Hematology Associates at John Stoddard Cancer Center Des Moines Iowa
United States Medical Oncology and Hematology Associates at Mercy Cancer Center Des Moines Iowa
United States Mercy Cancer Center at Mercy Medical Center - Des Moines Des Moines Iowa
United States Mercy Capitol Hospital Des Moines Iowa
United States Josephine Ford Cancer Center at Henry Ford Hospital Detroit Michigan
United States Cancer Center of Kansas, PA - Dodge City Dodge City Kansas
United States City of Hope Comprehensive Cancer Center Duarte California
United States Northeast Radiation Oncology Center Dunmore Pennsylvania
United States Dale and Frances Hughes Cancer Center at Pocono Medical Center East Stroudsburg Pennsylvania
United States Fairview Southdale Hospital Edina Minnesota
United States Cancer Center of Kansas, PA - El Dorado El Dorado Kansas
United States Elkhart General Hospital Elkhart Indiana
United States Union Hospital Cancer Program at Union Hospital Elkton Maryland
United States Green Bay Oncology, Limited - Escanaba Escanaba Michigan
United States Willamette Valley Cancer Center - Eugene Eugene Oregon
United States Eureka Community Hospital Eureka Illinois
United States Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital Fairbanks Alaska
United States CCOP - MeritCare Hospital Fargo North Dakota
United States MeritCare Broadway Fargo North Dakota
United States St. Francis Hospital Federal Way Washington
United States Genesys Hurley Cancer Institute Flint Michigan
United States Hurley Medical Center Flint Michigan
United States Poudre Valley Radiation Oncology Fort Collins Colorado
United States Parkview Regional Cancer Center at Parkview Health Fort Wayne Indiana
United States Radiation Oncology Associates Southwest Fort Wayne Indiana
United States Klabzuba Cancer Center at Harris Methodist Fort Worth Hospital Fort Worth Texas
United States Fredericksburg Oncology, Incorporated Fredericksburg Virginia
United States Mercy and Unity Cancer Center at Unity Hospital Fridley Minnesota
United States University of Florida Shands Cancer Center Gainesville Florida
United States Galesburg Clinic, PC Galesburg Illinois
United States Galesburg Cottage Hospital Galesburg Illinois
United States InterCommunity Cancer Center of Western Illinois Galesburg Illinois
United States Wayne Memorial Hospital, Incorporated Goldsboro North Carolina
United States Wayne Radiation Oncology Goldsboro North Carolina
United States Great Falls Clinic - Main Facility Great Falls Montana
United States Green Bay Oncology, Limited at St. Mary's Hospital Green Bay Wisconsin
United States Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center Green Bay Wisconsin
United States St. Mary's Hospital Medical Center - Green Bay Green Bay Wisconsin
United States St. Vincent Hospital Regional Cancer Center Green Bay Wisconsin
United States Legacy Mount Hood Medical Center Gresham Oregon
United States Van Elslander Cancer Center at St. John Hospital and Medical Center Grosse Pointe Woods Michigan
United States Mason District Hospital Havana Illinois
United States Northern Montana Hospital Havre Montana
United States Penn State Cancer Institute at Milton S. Hershey Medical Center Hershey Pennsylvania
United States Hopedale Medical Complex Hopedale Illinois
United States M. D. Anderson Cancer Center at University of Texas Houston Texas
United States Cancer Center of Kansas-Independence Independence Kansas
United States Cleveland Clinic Cancer Center Independence Ohio
United States Independence Regional Health Center Independence Missouri
United States Central Indiana Cancer Centers - East Indianapolis Indiana
United States Dickinson County Healthcare System Iron Mountain Michigan
United States Foote Memorial Hospital Jackson Michigan
United States Baptist Cancer Institute - Jacksonville Jacksonville Florida
United States Baptist Medical Center South Jacksonville Florida
United States Integrated Community Oncology Network at Southside Cancer Center Jacksonville Florida
United States Mayo Clinic - Jacksonville Jacksonville Florida
United States Integrated Community Oncology Network Jacksonville Beach Florida
United States Joliet Oncology-Hematology Associates, Limited - West Joliet Illinois
United States St. John's Regional Medical Center Joplin Missouri
United States Borgess Medical Center Kalamazoo Michigan
United States Bronson Methodist Hospital Kalamazoo Michigan
United States West Michigan Cancer Center Kalamazoo Michigan
United States Glacier Oncology, PLLC Kalispell Montana
United States Kalispell Medical Oncology at KRMC Kalispell Montana
United States Kalispell Regional Medical Center Kalispell Montana
United States CCOP - Kansas City Kansas City Missouri
United States Kansas City Cancer Centers - South Kansas City Missouri
United States North Kansas City Hospital Kansas City Missouri
United States Parvin Radiation Oncology Kansas City Missouri
United States Research Medical Center Kansas City Missouri
United States Saint Luke's Cancer Institute at Saint Luke's Hospital Kansas City Missouri
United States St. Joseph Medical Center Kansas City Missouri
United States Truman Medical Center - Hospital Hill Kansas City Missouri
United States Good Samaritan Cancer Center at Good Samaritan Hospital Kearney Nebraska
United States Kingsbury Center for Cancer Care at Cheshire Medical Center Keene New Hampshire
United States Cancer Center of Kansas, PA - Kingman Kingman Kansas
United States Cascade Cancer Center at Evergreen Hospital Medical Center Kirkland Washington
United States Thompson Cancer Survival Center Knoxville Tennessee
United States Thompson Cancer Survival Center West Knoxville Tennessee
United States Howard Community Hospital Kokomo Indiana
United States Gundersen Lutheran Center for Cancer and Blood La Crosse Wisconsin
United States Center for Cancer Therapy at LaPorte Hospital and Health Services La Porte Indiana
United States Monter Cancer Center of the North Shore-LIJ Health System Lake Success New York
United States Haematology-Oncology Associates of Ohio and Michigan, PC Lambertville Michigan
United States Fairfield Medical Center Lancaster Ohio
United States Sparrow Regional Cancer Center Lansing Michigan
United States CCOP - Nevada Cancer Research Foundation Las Vegas Nevada
United States University Medical Center of Southern Nevada Las Vegas Nevada
United States Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Lebanon New Hampshire
United States Tunnell Cancer Center at Beebe Medical Center Lewes Delaware
United States Southwest Medical Center Liberal Kansas
United States Liberty Hospital Liberty Missouri
United States Lima Memorial Hospital Lima Ohio
United States Cancer Resource Center - Lincoln Lincoln Nebraska
United States St. Barnabas Medical Center Cancer Center Livingston New Jersey
United States St. Mary Mercy Hospital Livonia Michigan
United States Kaiser Permanente Medical Center - Los Angeles Los Angeles California
United States Joe Arrington Cancer Research and Treatment Center Lubbock Texas
United States McDonough District Hospital Macomb Illinois
United States University of Wisconsin Paul P. Carbone Comprehensive Cancer Center Madison Wisconsin
United States CCOP - North Shore University Hospital Manhasset New York
United States Don Monti Comprehensive Cancer Center at North Shore University Hospital Manhasset New York
United States Minnesota Oncology Hematology, PA - Maplewood Maplewood Minnesota
United States Strecker Cancer Center at Marietta Memorial Hospital Marietta Ohio
United States Bay Area Cancer Care Center at Bay Area Medical Center Marinette Wisconsin
United States Mercy Cancer Center at Mercy Medical Center - North Iowa Mason City Iowa
United States Northwest Ohio Oncology Center Maumee Ohio
United States St. Luke's Hospital Maumee Ohio
United States Cardinal Bernardin Cancer Center at Loyola University Medical Center Maywood Illinois
United States Riddle Memorial Hospital Cancer Center Media Pennsylvania
United States Community Memorial Hospital Cancer Care Center Menomonee Falls Wisconsin
United States Baptist-South Miami Regional Cancer Program Miami Florida
United States Saint Anthony Memorial Health Centers Michigan City Indiana
United States Upper Delaware Valley Cancer Center Milford Pennsylvania
United States Providence Milwaukie Hospital Milwaukie Oregon
United States Virginia Piper Cancer Institute at Abbott - Northwestern Hospital Minneapolis Minnesota
United States Community Medical Center Missoula Montana
United States Guardian Oncology and Center for Wellness Missoula Montana
United States Montana Cancer Center at St. Patrick Hospital and Health Sciences Center Missoula Montana
United States Montana Cancer Specialists at Montana Cancer Center Missoula Montana
United States Community Cancer Center of Monroe Monroe Michigan
United States Mercy Memorial Hospital - Monroe Monroe Michigan
United States Intercommunity Cancer Center Monroeville Pennsylvania
United States Jon and Karen Huntsman Cancer Center at Intermountain Medical Center Murray Utah
United States Alle-Kiski Medical Center Natrona Heights Pennsylvania
United States Yale Cancer Center New Haven Connecticut
United States Long Island Jewish Medical Center New Hyde Park New York
United States Memorial Sloan-Kettering Cancer Center New York New York
United States CCOP - Christiana Care Health Services Newark Delaware
United States Licking Memorial Cancer Care Program at Licking Memorial Hospital Newark Ohio
United States Cancer Center of Kansas, PA - Newton Newton Kansas
United States Sentara Cancer Institute at Sentara Norfolk General Hospital Norfolk Virginia
United States BroMenn Regional Medical Center Normal Illinois
United States Community Cancer Center Normal Illinois
United States Thompson Cancer Survival Center at Methodist Oak Ridge Tennessee
United States Regional Cancer Center at Oconomowoc Memorial Hospital Oconomowoc Wisconsin
United States Green Bay Oncology, Limited - Oconto Falls Oconto Falls Wisconsin
United States Val and Ann Browning Cancer Center at McKay-Dee Hospital Center Ogden Utah
United States Oklahoma University Cancer Institute Oklahoma City Oklahoma
United States Alegant Health Cancer Center at Bergan Mercy Medical Center Omaha Nebraska
United States CCOP - Missouri Valley Cancer Consortium Omaha Nebraska
United States Creighton University Medical Center Omaha Nebraska
United States Immanuel Medical Center Omaha Nebraska
United States Methodist Estabrook Cancer Center Omaha Nebraska
United States Integrated Community Oncology Network - Orange Park Orange Park Florida
United States St. Charles Mercy Hospital Oregon Ohio
United States Toledo Clinic - Oregon Oregon Ohio
United States Community Hospital of Ottawa Ottawa Illinois
United States Oncology Hematology Associates of Central Illinois, PC - Ottawa Ottawa Illinois
United States Kansas City Cancer Centers - Southwest Overland Park Kansas
United States Menorah Medical Center Overland Park Kansas
United States Florida Cancer Center - Palatka Palatka Florida
United States Cancer Center of Paoli Memorial Hospital Paoli Pennsylvania
United States Cancer Center of Kansas, PA - Parsons Parsons Kansas
United States Cancer Treatment Center at Pekin Hospital Pekin Illinois
United States CCOP - Illinois Oncology Research Association Peoria Illinois
United States Methodist Medical Center of Illinois Peoria Illinois
United States Oncology Hematology Associates of Central Illinois, PC - Peoria Peoria Illinois
United States OSF St. Francis Medical Center Peoria Illinois
United States Proctor Hospital Peoria Illinois
United States Illinois Valley Community Hospital Peru Illinois
United States Fox Chase Cancer Center - Philadelphia Philadelphia Pennsylvania
United States Frankford Hospital Cancer Center - Torresdale Campus Philadelphia Pennsylvania
United States Kimmel Cancer Center at Thomas Jefferson University - Philadelphia Philadelphia Pennsylvania
United States Arizona Oncology Services Foundation Phoenix Arizona
United States Allegheny Cancer Center at Allegheny General Hospital Pittsburgh Pennsylvania
United States St. Joseph Mercy Oakland Pontiac Michigan
United States Mercy Regional Cancer Center at Mercy Hospital Port Huron Michigan
United States Adventist Medical Center Portland Oregon
United States CCOP - Columbia River Oncology Program Portland Oregon
United States Legacy Emanuel Hospital and Health Center and Children's Hospital Portland Oregon
United States Legacy Good Samaritan Hospital & Comprehensive Cancer Center Portland Oregon
United States Providence Cancer Center at Providence Portland Medical Center Portland Oregon
United States Providence St. Vincent Medical Center Portland Oregon
United States Hudson Valley Oncology Associates Poughkeepsie New York
United States Cancer Center of Kansas, PA - Pratt Pratt Kansas
United States Perry Memorial Hospital Princeton Illinois
United States Utah Valley Regional Medical Center - Provo Provo Utah
United States Rapid City Regional Hospital Rapid City South Dakota
United States McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center Reading Pennsylvania
United States Virginia Commonwealth University Massey Cancer Center Richmond Virginia
United States Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center Robbinsdale Minnesota
United States Lipson Cancer and Blood Center at Rochester General Hospital Rochester New York
United States Mayo Clinic Cancer Center Rochester Minnesota
United States Radiation Oncology Center - Roseville Roseville California
United States William Beaumont Hospital - Royal Oak Campus Royal Oak Michigan
United States Rutherford Hospital Rutherfordton North Carolina
United States Mercy General Hospital Sacramento California
United States Radiological Associates of Sacramento Medical Group, Incorporated Sacramento California
United States Seton Cancer Institute at Saint Mary's - Saginaw Saginaw Michigan
United States Flagler Cancer Center Saint Augustine Florida
United States CentraCare Clinic - River Campus Saint Cloud Minnesota
United States Coborn Cancer Center Saint Cloud Minnesota
United States Dixie Regional Medical Center - East Campus Saint George Utah
United States Norris Cotton Cancer Center - North Saint Johnsbury Vermont
United States Heartland Regional Medical Center Saint Joseph Missouri
United States Lakeland Regional Cancer Care Center - St. Joseph Saint Joseph Michigan
United States CCOP - Metro-Minnesota Saint Louis Park Minnesota
United States Park Nicollet Cancer Center Saint Louis Park Minnesota
United States United Hospital Saint Paul Minnesota
United States Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford Salem Ohio
United States Salem Hospital Regional Cancer Care Services Salem Oregon
United States Cancer Center of Kansas, PA - Salina Salina Kansas
United States Huntsman Cancer Institute at University of Utah Salt Lake City Utah
United States LDS Hospital Salt Lake City Utah
United States Utah Cancer Specialists at UCS Cancer Center Salt Lake City Utah
United States UCSF Helen Diller Family Comprehensive Cancer Center San Francisco California
United States North Coast Cancer Care, Incorporated Sandusky Ohio
United States Mayo Clinic Scottsdale Scottsdale Arizona
United States CCOP - Virginia Mason Research Center Seattle Washington
United States University Cancer Center at University of Washington Medical Center Seattle Washington
United States Shawnee Mission Medical Center Shawnee Mission Kansas
United States Texas Oncology, PA at Texas Cancer Center - Sherman Sherman Texas
United States Avera Cancer Institute Sioux Falls South Dakota
United States Medical X-Ray Center, PC Sioux Falls South Dakota
United States Sanford Cancer Center at Sanford USD Medical Center Sioux Falls South Dakota
United States Somerset Oncology Center Somerset Pennsylvania
United States CCOP - Northern Indiana CR Consortium South Bend Indiana
United States Memorial Hospital of South Bend South Bend Indiana
United States Saint Joseph Regional Medical Center South Bend Indiana
United States South Bend Clinic South Bend Indiana
United States Providence Cancer Institute at Providence Hospital - Southfield Campus Southfield Michigan
United States Frederick R. and Betty M. Smith Cancer Treatment Center Sparta New Jersey
United States CCOP - Upstate Carolina Spartanburg South Carolina
United States Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Spartanburg South Carolina
United States St. Margaret's Hospital Spring Valley Illinois
United States Valley Cancer Center Spring Valley Illinois
United States CCOP - Cancer Research for the Ozarks Springfield Missouri
United States Community Hospital of Springfield and Clark County Springfield Ohio
United States Hulston Cancer Center at Cox Medical Center South Springfield Missouri
United States Mercy Medical Center Springfield Ohio
United States St. John's Regional Health Center Springfield Missouri
United States Door County Cancer Center at Door County Memorial Hospital Sturgeon Bay Wisconsin
United States Green Bay Oncology, Limited - Sturgeon Bay Sturgeon Bay Wisconsin
United States Texas Oncology, PA at Texas Oncology Cancer Center Sugar Land Sugar Land Texas
United States Flower Hospital Cancer Center Sylvania Ohio
United States H. Lee Moffitt Cancer Center and Research Institute at University of South Florida Tampa Florida
United States Mercy Hospital of Tiffin Tiffin Ohio
United States CCOP - Toledo Community Hospital Toledo Ohio
United States Medical University of Ohio Cancer Center Toledo Ohio
United States St. Vincent Mercy Medical Center Toledo Ohio
United States Toledo Clinic, Incorporated - Main Clinic Toledo Ohio
United States Toledo Hospital Toledo Ohio
United States Legacy Meridian Park Hospital Tualatin Oregon
United States Arizona Oncology - Tucson Tucson Arizona
United States Natalie Warren Bryant Cancer Center at St. Francis Hospital Tulsa Oklahoma
United States Carle Cancer Center at Carle Foundation Hospital Urbana Illinois
United States CCOP - Carle Cancer Center Urbana Illinois
United States Solano Radiation Oncology Center Vacaville California
United States Southwest Washington Medical Center Cancer Center Vancouver Washington
United States Cancer Institute of New Jersey at Cooper - Voorhees Voorhees New Jersey
United States Ridgeview Medical Center Waconia Minnesota
United States St. John Macomb Hospital Warren Michigan
United States Waukesha Memorial Hospital Regional Cancer Center Waukesha Wisconsin
United States Fulton County Health Center Wauseon Ohio
United States Cancer Center of Kansas, PA - Wellington Wellington Kansas
United States Mount Carmel St. Ann's Cancer Center Westerville Ohio
United States Associates in Womens Health, PA - North Review Wichita Kansas
United States Cancer Center of Kansas, PA - Medical Arts Tower Wichita Kansas
United States Cancer Center of Kansas, PA - Wichita Wichita Kansas
United States CCOP - Wichita Wichita Kansas
United States Via Christi Cancer Center at Via Christi Regional Medical Center Wichita Kansas
United States Wesley Medical Center Wichita Kansas
United States Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center Wilkes-Barre Pennsylvania
United States Wilmed Radiation Oncology Services Wilson North Carolina
United States Cancer Center of Kansas, PA - Winfield Winfield Kansas
United States Minnesota Oncology Hematology, PA - Woodbury Woodbury Minnesota
United States Cancer Treatment Center Wooster Ohio
United States CCOP - Main Line Health Wynnewood Pennsylvania
United States Lankenau Cancer Center at Lankenau Hospital Wynnewood Pennsylvania
United States North Star Lodge Cancer Center at Yakima Valley Memorial Hospital Yakima Washington
United States Genesis - Good Samaritan Hospital Zanesville Ohio

Sponsors (4)

Lead Sponsor Collaborator
Radiation Therapy Oncology Group European Organisation for Research and Treatment of Cancer - EORTC, National Cancer Institute (NCI), NRG Oncology

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (5)

Aldape KD, Jones G, Wang M, et al.: MGMT methylation testing in RTOG 0525: A phase III trial of newly diagnosed glioblastoma. [Abstract] J Clin Oncol 27 (Suppl 15): A-2051, 2009.

Aldape KD, Wang M, Sulman EP, et al.: RTOG 0525: molecular correlates from a randomized phase III trial of newly diagnosed glioblastoma. [Abstract] J Clin Oncol 29 (Suppl 15): A-LBA2000, 2011.

Armstrong TS, Wefel JS, Wang M, et al.: Clinical utility of neurocognitive function (NCF), quality of life (QOL), and symptom assessment as prognostic factors for survival and measures of treatment effects on RTOG 0525. [Abstract] J Clin Oncol 29 (Suppl 1

Gilbert MR, Wang M, Aldape KD, Stupp R, Hegi ME, Jaeckle KA, Armstrong TS, Wefel JS, Won M, Blumenthal DT, Mahajan A, Schultz CJ, Erridge S, Baumert B, Hopkins KI, Tzuk-Shina T, Brown PD, Chakravarti A, Curran WJ Jr, Mehta MP. Dose-dense temozolomide for — View Citation

Wang M, Dignam J, Won M, et al.: Variation over time and interdependence between disease progression and death among patients with glioblastoma (GBM) on RTOG 0525. [Abstract] J Clin Oncol 29 (Suppl 15): A-2017, 2011.

Outcome

Type Measure Description Time frame Safety issue
Primary Median Overall Survival Time Overall survival time is defined as time from registration/randomization to the date of death from any cause. Overall survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. Analysis occurred after 647 deaths were reported. From randomization to last follow-up. Maximum follow-up at time of analysis was 4.4 years.
Secondary Median Progression-free Survival (PFS) Time Progression is defined as greater than 25% increase in tumor area (two diameters) provided that the patient has not had his/her dose of steroids decreased since the last evaluation period. Progression-free survival time is defined as time from registration to the date of first progression, death, or last known follow-up (censored). Progression-free survival rates are estimated using the Kaplan-Meier method. A concomitant decrease in steroid dose will rule out a progression designation during the first 2 months after completion of radiation therapy. Analysis occurred after 647 deaths were reported. From randomization to last follow-up. Maximum follow-up at time of analysis was 4.4 years.
Secondary Median Overall Survival Time by MGMT Status Overall survival time is defined as time from randomization to the date of death from any cause. Overall survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. Tumor tissue submitted at baseline was analyzed to determine MGMT (O[6]-methylguanine-DNA methyltransferase) promoter methylation status (methylated / unmethylated). Analysis occurred after 647 deaths were reported. From randomization to last follow-up. Maximum follow-up at time of analysis was 4.4 years.
Secondary Median Progression-free Survival Time by MGMT Status Progression is defined as greater than 25% increase in tumor area (two diameters) provided that the patient has not had his/her dose of steroids decreased since the last evaluation period. Progression-free survival time is defined as time from registration to the date of first progression, death, or last known follow-up (censored). Progression-free survival rates are estimated using the Kaplan-Meier method. A concomitant decrease in steroid dose will rule out a progression designation during the first 2 months after completion of radiation therapy. Tumor tissue submitted at baseline was analyzed to determine MGMT (O[6]-methylguanine-DNA methyltransferase) promoter methylation status (methylated / unmethylated). Analysis occurred after 647 deaths were reported. From randomization to last follow-up. Maximum follow-up at time of analysis was 4.4 years.
Secondary Best Treatment Response by MGMT Status Response assessed using Response Evaluation Criteria in Solid Tumors (RECIST v1.0): Complete Response (CR), imaging no longer shows enhancing tumor, confirmed by a second scan = 4 weeks later; Partial Response (PR), >=50% decrease in tumor area (two diameters) with patient off all steroids, or on adrenal maintenance only; Minor Response (MR), < 50% decrease in tumor area with patient off all steroids, or on adrenal maintenance only; Stable Disease (SD): scan shows no change with patient receiving stable/decreasing doses of steroids; Progression (P): > 25% increase in tumor area with no decrease in steroid dose since last evaluation. Tumor tissue submitted at baseline was analyzed to determine MGMT (O[6]-methylguanine-DNA methyltransferase) promoter methylation status (methylated / unmethylated). Analysis occurred after 647 deaths were reported. From randomization to last follow-up. Maximum follow-up at time of analysis was 4.4 years.
Secondary Distribution of Highest Grade AE Reported as Possibly/Probably/Definitely Related to Protocol Treatment Highest grade adverse event (AE) per subject was counted. Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE. Analysis occurred after 647 deaths were reported. From randomization to last follow-up. Maximum follow-up at time of analysis was 4.4 years.
Secondary Overall Survival Status by Progression Status at 6 Months Overall survival time is defined as time from registration to the date of death from any cause or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. Progression is defined as greater than 25% increase in tumor area (two diameters) provided that the patient has not had his/her dose of steroids decreased since the last evaluation period. From randomization to last follow-up. Maximum follow-up at time of analysis was 4.4 years.
Secondary Mean MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom Severity Score at Cycle 10 for Participants Without Progression After 6 Months of Adjuvant Therapy The MDASI-BT is a 28-item patient-reported outcome measure assessing symptom severity and resulting interference with daily living in brain cancer patients. All items range from 0 (not present) to 10 (as bad as you can imagine). The symptom severity score is the average of the symptom severity items, given a specified minimum numbers were completed. Baseline and cycle 10 (approximately 46 weeks)
Secondary Mean Neurocognitive Function (NCF) Composite Score at Cycle 10 for Participants Without Progression After 6 Months of Adjuvant Therapy The NCF Composite score is the arithmetic mean of the Hopkins Verbal Learning Test - Revised (HVLT-R) (Free Recall, Delayed Recall, Delayed Recognition), Trail Making Test Part A (TMTA), Trail Making Test Part B (TMTB), and Controlled Oral Word Association (COWA) test scores, all of which are standardized, adjusting for age, education, and gender as necessary, such that mean is 0 and standard deviation is 1. A participant must have at least 5 of the 6 scores. A higher composite score indicates better neurocognitive function. Baseline and cycle 10 (approximately 46 weeks)
Secondary Mean EORTC QLQ-C30 Global Health Status Score at Cycle 10 for Participants Without Progression After 6 Months of Adjuvant Therapy Global Health Status is calculated from two questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ]-C30. The question responses range from 1 "very poor" to 7 "excellent" such that a higher response indicates better quality of life (QOL). The mean of these responses is linearly transformed to a range of 0 (worst) to 100 (best). Baseline and cycle 10 (approximately 46 weeks)
Secondary Mean Change From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom Severity Score at Mid-cyle for Cycle 1 The MDASI-BT is a 28-item patient-reported outcome measure assessing symptom severity and resulting interference with daily living in brain cancer patients. All items range from 0 (not present) to 10 (as bad as you can imagine). The symptom severity score is the average of the symptom severity items, given a specified minimum numbers were completed. A score worse than baseline by at least one is considered deterioration. Change is calculated as time point - baseline such that a positive change value indicates worse symptoms compared to baseline. Baseline and mid-cycle 1 (approximately 12 weeks)
Secondary Mean Change From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom Severity Score at Mid-cyle for Cycle 4 The MDASI-BT is a 28-item patient-reported outcome measure assessing symptom severity and resulting interference with daily living in brain cancer patients. All items range from 0 (not present) to 10 (as bad as you can imagine). The symptom severity score is the average of the symptom severity items, given a specified minimum numbers were completed. A score worse than baseline by at least one is considered deterioration. Change is calculated as time point - baseline such that a positive change value indicates worse symptoms compared to baseline. Baseline and mid-cycle 4 (approximately 24 weeks)
Secondary Mean Change From Baseline in EORTC QLQ-C30 Global Health Status Score at Mid-cyle for Cycle 1 Global Health Status is calculated from two questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ]-C30. The question responses range from 1 "very poor" to 7 "excellent" such that a higher response indicates better quality of life (QOL). The mean of these responses is linearly transformed to a range of 0 (worst) to 100 (best). Change is calculated as time point - baseline such that a positive change value indicates worse symptoms compared to baseline. Baseline and mid-cycle 1 (approximately 12 weeks)
Secondary Mean Change From Baseline in EORTC QLQ-C30 Global Health Status Score at Mid-cyle for Cycle 4 Global Health Status is calculated from two questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ]-C30. The question responses range from 1 "very poor" to 7 "excellent" such that a higher response indicates better quality of life (QOL). The mean of these responses is linearly transformed to a range of 0 (worst) to 100 (best). Change is calculated as time point - baseline such that a positive change value indicates worse symptoms compared to baseline. Baseline and mid-cycle 4 (approximately 24 weeks)
Secondary Change From Baseline in Mean EORTC QLQ-C30 Global Health Status Global Health Status is calculated from two questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ]-C30. The question responses range from 1 "very poor" to 7 "excellent" such that a higher response indicates better quality of life (QOL). The mean of these responses is linearly transformed to a range of 0 (worst) to 100 (best). Change from baseline was calculated as time point value - baseline value with a positive change value indicating improved QOL from baseline. Baseline, 10,12, 22, 24, and 46 weeks
Secondary Number of Participants With Deterioration From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom Severity Score at Cycle 4 The MDASI-BT is a 28-item patient-reported outcome measure assessing symptom severity and resulting interference with daily living in brain cancer patients. All items range from 0 (not present) to 10 (as bad as you can imagine). The symptom severity score is the average of the symptom severity items, given a specified minimum numbers were completed. A score worse than baseline by at least one is considered deterioration. baseline and cycle 4 (approximately 22 weeks)
Secondary Number of Participants With Deterioration From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Interference Score at Cycle 4 The MDASI-BT is a 28-item patient-reported outcome measure assessing symptom severity and resulting interference with daily living in brain cancer patients. All items range from 0 (did not interfere) to 10 (interfered completely). The symptom interference score is the average of the symptom interference items, given a specified minimum numbers were completed. A score worse than baseline by at least one is considered deterioration. baseline and cycle 4 (approximately 22 weeks)
Secondary Number of Participants With Deterioration From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom Severity Score and EORTC QLQ-C30 Global Health Status Score (GHS) at Cycle 1 The MDASI-BT is a 28-item patient-reported outcome measure assessing symptom severity (SS) and resulting interference with daily living in brain cancer patients. All items range from 0 (not present) to 10 (as bad as you can imagine). A SS score is the average of the SS items, given a specified minimum numbers were completed. A score worse than baseline by at least one is considered deterioration.
Global Health Status is calculated from two questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ]-C30. The question responses range from 1 (very poor) to 7 (excellent) such that a higher response indicates better quality of life (QOL). The mean of these responses is linearly transformed to a range of 0 (worst) to 100 (best). A score worse than baseline by at least 10 is considered deterioration.
The 2x2 frequency table of SS deterioration vs. GHS deterioration is presented as four rows.
baseline and cycle 1 (approximately 10 weeks)
Secondary Number of Participants With Deterioration From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom Severity Score and EORTC QLQ-C30 Global Health Status Score (GHS) at Cycle 4 The MDASI-BT is a 28-item patient-reported outcome measure assessing symptom severity (SS) and resulting interference with daily living in brain cancer patients. All items range from 0 (not present) to 10 (as bad as you can imagine). A SS score is the average of the SS items, given a specified minimum numbers were completed. A score worse than baseline by at least one is considered deterioration.
Global Health Status is calculated from two questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ]-C30. The question responses range from 1 (very poor) to 7 (excellent) such that a higher response indicates better quality of life (QOL). The mean of these responses is linearly transformed to a range of 0 (worst) to 100 (best). A score worse than baseline by at least 10 is considered deterioration.
The 2x2 frequency table of SS deterioration vs. GHS deterioration is presented as four rows.
baseline and cycle 4 (approximately 22 weeks)
Secondary Number of Participants With Deterioration From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom Severity Score and EORTC QLQ-C30 Global Health Status Score (GHS) at Cycle 10 The MDASI-BT is a 28-item patient-reported outcome measure assessing symptom severity (SS) and resulting interference with daily living in brain cancer patients. All items range from 0 (not present) to 10 (as bad as you can imagine). A SS score is the average of the SS items, given a specified minimum numbers were completed. A score worse than baseline by at least one is considered deterioration.
Global Health Status is calculated from two questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ]-C30. The question responses range from 1 (very poor) to 7 (excellent) such that a higher response indicates better quality of life (QOL). The mean of these responses is linearly transformed to a range of 0 (worst) to 100 (best). A score worse than baseline by at least 10 is considered deterioration.
The 2x2 frequency table of SS deterioration vs. GHS deterioration is presented as four rows.
baseline and cycle 10 (approximately 46 weeks)
Secondary Mean MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom Severity Score Over Time The MDASI-BT is a 28-item patient-reported outcome measure assessing symptom severity and resulting interference with daily living in brain cancer patients. All items range from 0 (not present) to 10 (as bad as you can imagine). The symptom severity score is the average of the symptom severity items, given a specified minimum numbers were completed. Baseline, 10, 12, 22, 24, and 46 weeks
Secondary Determination of Impactful Baseline Instruments on Overall Survival Overall survival time is defined as time from registration/randomization to the date of death from any cause or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ]-C30 subscales are calculated as the mean of component items, then standardized such that subscale scores range from 0 to 100. A high score for a functional scale represents a healthy level of functioning. Controlled Oral Word Association (COWA) score is the sum of correct responses with a range of 0 to infinity. A higher score indicates better functioning. Hopkins Verbal Learning Test - Revised (HVLT-R) score ranges from 0 to 36 for total recall is 0 to 36, 0 to 12 for delayed recall, and -12 to 12 for recognition. A higher score indicates better functioning. From randomization to last follow-up. Maximum follow-up at time of analysis was 4.4 years.
Secondary Mean Neurocognitive Function (NCF) Composite Score Over Time The NCF Composite score is the arithmetic mean of the HVLT-R (Free Recall, Delayed Recall, Delayed Recognition), TMTA, TMTB, and COWA scores, all of which are standardized, adjusting for age, education, and gender as necessary, such that mean is 0 and standard deviation is 1. A participant must have at least 5 of the 6 scores. A higher composite score indicates better neurocognitive function. Baseline, 10, 22, and 46 weeks
Secondary Number of Participants With Deterioration From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Cognitive Score and Hopkins Verbal Learning Test - Revised (HVLT-R) Delayed Recognition Score at Cycle 1 The MDASI-BT is a 28-item patient-reported outcome measure assessing symptom severity (SS) and resulting interference with daily living in brain cancer patients. All items range from 0 (not present) to 10 (as bad as you can imagine). A SS score is the average of the SS items, given a specified minimum numbers were completed. A score worse than baseline by at least one is considered deterioration.
The HVLT-R Delayed Recognition raw score is the number of of correctly identified words minus the number of incorrectly identified words from a list of words including 12 nouns memorized 20 minutes prior. The raw score ranges from -12 to 12. with a higher score indicates better functioning. Scores are standardized (mean 0, standard deviation 1), adjusting for age,education, and gender as necessary. A score worse than baseline by at least two is considered deterioration.
The 2x2 frequency table of SS deterioration vs. HVLT-R deterioration is presented as four rows.
baseline and cycle 1 (approximately 10 weeks)
Secondary Number of Participants With Deterioration From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Cognitive Score and Hopkins Verbal Learning Test - Revised (HVLT-R) Delayed Recognition (DR) Score at Cycle 4 The MDASI-BT is a 28-item patient-reported outcome measure assessing symptom severity (SS) and resulting interference with daily living in brain cancer patients. All items range from 0 (not present) to 10 (as bad as you can imagine). A SS score is the average of the SS items, given a specified minimum numbers were completed. A score worse than baseline by at least one is considered deterioration.
The HVLT-R Delayed Recognition raw score is the number of of correctly identified words minus the number of incorrectly identified words from a list of words including 12 nouns memorized 20 minutes prior. The raw score ranges from -12 to 12. with a higher score indicates better functioning. Scores are standardized (mean 0, standard deviation 1), adjusting for age,education, and gender as necessary. A score worse than baseline by at least two is considered deterioration.
The 2x2 frequency table of SS deterioration vs. HVLT-R deterioration is presented as four rows.
baseline and cycle 4 (approximately 22 weeks)
Secondary Number of Participants With Deterioration From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Cognitive Score and Hopkins Verbal Learning Test - Revised (HVLT-R) Delayed Recognition (DR) Score at Cycle 10 The MDASI-BT is a 28-item patient-reported outcome measure assessing symptom severity (SS) and resulting interference with daily living in brain cancer patients. All items range from 0 (not present) to 10 (as bad as you can imagine). A SS score is the average of the SS items, given a specified minimum numbers were completed. A score worse than baseline by at least one is considered deterioration.
The HVLT-R Delayed Recognition raw score is the number of of correctly identified words minus the number of incorrectly identified words from a list of words including 12 nouns memorized 20 minutes prior. The raw score ranges from -12 to 12. with a higher score indicates better functioning. Scores are standardized (mean 0, standard deviation 1), adjusting for age,education, and gender as necessary. A score worse than baseline by at least two is considered deterioration.
The 2x2 frequency table of SS deterioration vs. HVLT-R deterioration is presented as four rows.
baseline and cycle 10 (approximately 46 weeks)
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