Brain and Central Nervous System Tumors Clinical Trial
Official title:
Phase III Trial Comparing Conventional Adjuvant Temozolomide With Dose-Intensive Temozolomide in Patients With Newly Diagnosed Glioblastoma
Verified date | May 2020 |
Source | Radiation Therapy Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Radiation Therapy Oncology Group | European Organisation for Research and Treatment of Cancer - EORTC, National Cancer Institute (NCI), NRG Oncology |
United States, Canada,
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.
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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