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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01198145
Other study ID # NCCTG-N08C9
Secondary ID NCI-2011-02602CD
Status Completed
Phase Phase 3
First received
Last updated
Start date April 2011
Est. completion date July 15, 2017

Study information

Verified date April 2020
Source Alliance for Clinical Trials in Oncology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

RATIONALE: Sulfasalazine may relieve diarrhea in patients with cancer who are undergoing pelvic radiation therapy.

PURPOSE: This randomized phase III trial is studying sulfasalazine to see how well it works in preventing acute diarrhea in patients with cancer who are undergoing pelvic radiation therapy.


Description:

OBJECTIVES:

Primary

- To determine whether sulfasalazine is effective in reducing the acute treatment-related diarrhea in patients receiving pelvic radiotherapy as measured by NCI CTC v4.0 in patients receiving pelvic external-beam radiotherapy as adjuvant or primary treatment for malignancy.

Secondary

- To determine whether sulfasalazine can reduce chronic treatment-related bowel dysfunction following completion of therapy.

- To determine whether sulfasalazine causes any toxicity in this situation.

Tertiary

- To bank blood products for future studies, as part of ongoing research for NCCTG studies (Mayo Clinic Rochester only). (Translational)

OUTLINE: This is a multicenter study. Patients are stratified according to history of anterior resection of the rectum (yes vs no); total planned cumulative dosing, including boost fields of external-beam radiotherapy (4500-5350 cGy vs > 5350 cGy); and concurrent radiosensitizing fluorouracil, capecitabine, or oxaliplatin (yes vs no). Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive oral sulfasalazine twice daily during radiotherapy* and for 4 weeks after completion of radiotherapy.

- Arm II: Patients receive oral placebo twice daily during radiotherapy* and for 4 weeks after completion of radiotherapy.

NOTE: *Patients must start study treatment by the third radiotherapy fraction.

Patients may undergo blood sample collection at baseline and then weekly during radiotherapy. All patients complete quality of life and bowel function questionnaires at baseline, weekly during radiotherapy, and at 6 weeks after completion of radiotherapy.

After completion of radiotherapy, patients are followed up at 6 weeks and at 12 and 24 months.


Recruitment information / eligibility

Status Completed
Enrollment 87
Est. completion date July 15, 2017
Est. primary completion date July 22, 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility DISEASE CHARACTERISTICS:

- Diagnosis of cancer that supports the use of radiotherapy to the pelvis

- No current or prior metastases beyond pelvic regional lymph nodes

- Planning to receive a course of continuous definitive or adjuvant external-beam radiotherapy to a minimum dose of 4500 cGy with or without fluorouracil, capecitabine, or oxaliplatin

- Planned course of pelvic radiotherapy must fall within the following parameters:

- Pelvis must be encompassed by the planned radiotherapy fields

- Superior border may not lie superior to the L4-5 interspace and may not be inferior to the most inferior aspect of the sacroiliac joints

- Portions of the rectum may have special blocking, depending upon disease site

- Total planned dose to the central axis midplane (for AP-PA parallel opposed fields) or isocenter (for 3- or 4-field techniques) for the pelvic field must lie between 4500-5300 cGy (inclusive)*

- Subsequent to completion of treatment to the pelvic field, a boost to primary tumor or tumor bed may be planned

- Planned treatment is to be given 4-5 times per week on a one-treatment-per-day basis

- Daily dose (specified at central axis midplane or at isocenter for multi-field techniques) must lie between 170-210 cGy (inclusive) per day*

- NOTE: *For institutions that do not use midplane or isocenter as the point for specification of dose, it will be necessary to determine the dose according to the methods specified above in order to determine patient eligibility.

- No perineal irradiation planned (e.g., anal cancer patients, patients who have had an abdominal-perineal resection)

- No brachytherapy planned before the completion of all external-beam radiotherapy

- No planned split-course radiotherapy

PATIENT CHARACTERISTICS:

- ECOG performance status 0-2

- Life expectancy = 6 months

- Hemoglobin = 10.0 g/dL

- Leukocytes = 3,500/mm^3

- ANC = 1,500/mm^3

- Platelet count = 100,000/mm^3

- Creatinine = 1.5 times upper limit of normal (ULN)

- AST = 1.5 times ULN

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Willing to provide blood specimens as required by the study (Mayo Clinic Rochester patients only)

- Able to complete questionnaires alone or with assistance

- No history of inflammatory bowel disease

- No history of gastrointestinal or genitourinary obstruction or porphyria

- No history of G6PD deficiency

- No history of irritable bowel syndrome

- No history of blood dyscrasia

- No history of severe allergies or asthma

- No history of hepatic or renal disease

- No diarrhea = grade 3, rectal bleeding, abdominal cramping, or incontinence of stool within the past week

- No medical condition that may interfere with the ability to receive study treatment

- No known allergy to sulfasalazine, sulfa medications, salicylates, or any known component of drug formulation

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No prior pelvic radiotherapy

- No prior abdominal-perineal resection, Hartmann procedure, or other surgical procedure leaving the patient without a functioning rectum

- No planned use of leucovorin or cytotoxic chemotherapeutic agents concurrent with radiotherapy (except for fluorouracil, capecitabine, or oxaliplatin)

- No other concurrent sulfasalazine

- No concurrent digoxin

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
sulfasalazine
Given orally
Other:
placebo
Given orally

Locations

Country Name City State
United States Kapiolani Medical Center at Pali Momi 'Aiea Hawaii
United States Hickman Cancer Center at Bixby Medical Center Adrian Michigan
United States University of New Mexico Cancer Center Albuquerque New Mexico
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 Randolph Hospital Asheboro North Carolina
United States MBCCOP - Medical College of Georgia Cancer Center Augusta Georgia
United States Aurora Presbyterian Hospital Aurora Colorado
United States Rush-Copley Cancer Care Center Aurora Illinois
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 St. Vincent Healthcare Cancer Care Services Billings Montana
United States Medcenter One Hospital Cancer Care Center Bismarck North Dakota
United States Mid Dakota Clinic, PC Bismarck North Dakota
United States St. Alexius Medical Center Cancer Center Bismarck North Dakota
United States Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center Boise Idaho
United States Central Care Cancer Center at Carrie J. Babb Cancer Center Bolivar Missouri
United States Boston University Cancer Research Center Boston Massachusetts
United States Boulder Community Hospital Boulder Colorado
United States Wood County Oncology Center Bowling Green Ohio
United States Bozeman Deaconess Cancer Center Bozeman Montana
United States St. Joseph's Medical Center Brainerd Minnesota
United States Fairview Ridges Hospital Burnsville Minnesota
United States St. James Healthcare Cancer Care Butte Montana
United States Southeast Cancer Center Cape Girardeau Missouri
United States Cedar Rapids Oncology Associates Cedar Rapids Iowa
United States Mercy Regional Cancer Center at Mercy Medical Center Cedar Rapids Iowa
United States Cancer Center of Kansas, PA - Chanute Chanute Kansas
United States Louis A. Weiss Memorial Hospital Chicago Illinois
United States Adena Regional Medical Center Chillicothe Ohio
United States Medical Oncology and Hematology Associates - West Des Moines Clive Iowa
United States Mercy Cancer Center - West Lakes Clive Iowa
United States Penrose Cancer Center at Penrose Hospital Colorado Springs Colorado
United States Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center Columbus Ohio
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 Mount Carmel Health - West Hospital Columbus Ohio
United States Riverside Methodist Hospital Cancer Care Columbus Ohio
United States New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care Concord New Hampshire
United States Mercy and Unity Cancer Center at Mercy Hospital Coon Rapids Minnesota
United States CCOP - Dayton Dayton Ohio
United States David L. Rike Cancer Center at Miami Valley Hospital Dayton Ohio
United States Good Samaritan Hospital Dayton Ohio
United States Grandview Hospital Dayton Ohio
United States Samaritan North Cancer Care Center Dayton Ohio
United States Oakwood Cancer Center at Oakwood Hospital and Medical Center Dearborn Michigan
United States Grady Memorial Hospital Delaware Ohio
United States Porter Adventist Hospital Denver Colorado
United States Presbyterian - St. Luke's Medical Center Denver Colorado
United States Rose Medical Center Denver Colorado
United States St. Anthony Central Hospital Denver Colorado
United States St. Joseph Hospital Denver Colorado
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 Cancer Center of Kansas, PA - Dodge City Dodge City Kansas
United States CCOP - Duluth Duluth Minnesota
United States Essentia Health - Duluth Clinic Duluth Minnesota
United States Miller - Dwan Medical Center Duluth Minnesota
United States Center for Cancer Treatment & Prevention at Sacred Heart Hospital Eau Claire Wisconsin
United States Marshfield Clinic Cancer Care at Regional Cancer Center Eau Claire Wisconsin
United States Fairview Southdale Hospital Edina Minnesota
United States Cancer Center of Kansas, PA - El Dorado El Dorado Kansas
United States Elkhart Clinic, LLC Elkhart Indiana
United States Elkhart General Hospital Elkhart Indiana
United States Michiana Hematology-Oncology, PC - Elkhart Elkhart Indiana
United States Union Hospital of Cecil County Elkton Maryland
United States Community Cancer Center Elyria Ohio
United States Hematology Oncology Center Elyria Ohio
United States Swedish Medical Center Englewood Colorado
United States MeritCare Broadway Fargo North Dakota
United States Blanchard Valley Medical Associates Findlay Ohio
United States Genesys Hurley Cancer Institute Flint Michigan
United States Hurley Medical Center Flint Michigan
United States Central Wisconsin Cancer Program at Agnesian HealthCare Fond Du Lac Wisconsin
United States Cancer Center of Kansas - Fort Scott Fort Scott Kansas
United States Middletown Regional Hospital Franklin Ohio
United States Fredericksburg Oncology, Incorporated Fredericksburg Virginia
United States Mercy and Unity Cancer Center at Unity Hospital Fridley Minnesota
United States CaroMont Cancer Center at Gaston Memorial Hospital Gastonia North Carolina
United States Wayne Memorial Hospital, Incorporated Goldsboro North Carolina
United States Altru Cancer Center at Altru Hospital Grand Forks North Dakota
United States Benefis Sletten Cancer Institute Great Falls Montana
United States North Colorado Medical Center Greeley Colorado
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 Moses Cone Regional Cancer Center at Wesley Long Community Hospital Greensboro North Carolina
United States Bon Secours St. Francis Health System Greenville South Carolina
United States Cancer Centers of the Carolinas - Faris Road Greenville South Carolina
United States CCOP - Greenville Greenville South Carolina
United States Greenville Hospital Cancer Center Greenville South Carolina
United States Wayne Hospital Greenville Ohio
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 Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center Hartford Connecticut
United States Ingalls Cancer Care Center at Ingalls Memorial Hospital Harvey Illinois
United States St. Peter's Hospital Helena Montana
United States Park Ridge Hospital Hendersonville North Carolina
United States High Point Regional Hospital High Point North Carolina
United States Cancer Research Center of Hawaii Honolulu Hawaii
United States Hawaii Medical Center - East Honolulu Hawaii
United States Kapiolani Medical Center for Women and Children Honolulu Hawaii
United States OnCare Hawaii, Incorporated - Kuakini Honolulu Hawaii
United States OnCare Hawaii, Incorporated - Lusitana Honolulu Hawaii
United States Queen's Cancer Institute at Queen's Medical Center Honolulu Hawaii
United States Straub Clinic and Hospital, Incorporated Honolulu Hawaii
United States Tripler Army Medical Center Honolulu Hawaii
United States New Hampshire Oncology - Hematology, PA - Hooksett Hooksett New Hampshire
United States Edwards Comprehensive Cancer Center at Cabell Huntington Hospital Huntington West Virginia
United States Hutchinson Area Health Care Hutchinson Minnesota
United States Cancer Center of Kansas-Independence Independence Kansas
United States St. Francis Hospital Cancer Care Services Indianapolis Indiana
United States Foote Memorial Hospital Jackson Michigan
United States Goldschmidt Cancer Center Jefferson City Missouri
United States Kalispell Regional Medical Center Kalispell Montana
United States Charles F. Kettering Memorial Hospital Kettering Ohio
United States Cancer Center of Kansas, PA - Kingman Kingman Kansas
United States Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center Kingsport Tennessee
United States Howard Community Hospital Kokomo Indiana
United States Gundersen Lutheran Center for Cancer and Blood La Crosse Wisconsin
United States Lakes Region General Hospital Laconia New Hampshire
United States Fairfield Medical Center Lancaster Ohio
United States Sparrow Regional Cancer Center Lansing Michigan
United States University of New Mexico Cancer Center - South Las Cruces New Mexico
United States Lawrence Memorial Hospital Lawrence Kansas
United States Tunnell Cancer Center at Beebe Medical Center Lewes Delaware
United States Cancer Center of Kansas, PA - Liberal Liberal Kansas
United States Lima Memorial Hospital Lima Ohio
United States Cancer Resource Center - Lincoln Lincoln Nebraska
United States St. Mary Mercy Hospital Livonia Michigan
United States Sky Ridge Medical Center Lone Tree Colorado
United States Hope Cancer Care Center at Longmont United Hospital Longmont Colorado
United States McKee Medical Center Loveland Colorado
United States Holy Family Memorial Medical Center Cancer Care Center Manitowoc Wisconsin
United States Immanuel St. Joseph's Mankato Minnesota
United States HealthEast Cancer Care at St. John's Hospital Maplewood Minnesota
United States Minnesota Oncology - 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 Marshfield Clinic - Marshfield Center Marshfield Wisconsin
United States Saint Joseph's Hospital Marshfield Wisconsin
United States Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County Martinsville Virginia
United States Northwest Ohio Oncology Center Maumee Ohio
United States Hennepin County Medical Center - Minneapolis Minneapolis Minnesota
United States Virginia Piper Cancer Institute at Abbott - Northwestern Hospital Minneapolis Minnesota
United States Marshfield Clinic - Lakeland Center Minocqua Wisconsin
United States Michiana Hematology-Oncology, PC - South Bend Mishawaka Indiana
United States Saint Joseph Regional Medical Center Mishawaka Indiana
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 Trinity Cancer Center at Trinity Medical Center - 7th Street Campus Moline Illinois
United States Community Cancer Center of Monroe Monroe Michigan
United States Mercy Memorial Hospital - Monroe Monroe Michigan
United States Mount Kisco Medical Group, PC Mount Kisco New York
United States Knox Community Hospital Mount Vernon Ohio
United States Ochsner Cancer Institute at Ochsner Clinic Foundation New Orleans Louisiana
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 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 Lakeside Hospital Omaha Nebraska
United States St. Charles Mercy Hospital Oregon Ohio
United States Toledo Clinic - Oregon Oregon Ohio
United States Cancer Center of Kansas, PA - Parsons Parsons Kansas
United States Mayo Clinic Hospital Phoenix Arizona
United States Michiana Hematology Oncology PC - Plymouth Plymouth Indiana
United States St. Joseph Mercy Oakland Pontiac Michigan
United States Mercy Regional Cancer Center at Mercy Hospital Port Huron Michigan
United States Legacy Good Samaritan Hospital & Comprehensive Cancer Center Portland Oregon
United States Cancer Center of Kansas, PA - Pratt Pratt Kansas
United States St. Mary - Corwin Regional Medical Center Pueblo Colorado
United States Rapid City Regional Hospital Rapid City South Dakota
United States Annie Penn Cancer Center Reidsville North Carolina
United States Ministry Medical Group at Saint Mary's Hospital Rhinelander Wisconsin
United States Marshfield Clinic - Indianhead Center Rice Lake Wisconsin
United States Reid Hospital & Health Care Services Richmond Indiana
United States Humphrey Cancer Center at North Memorial Outpatient Center Robbinsdale Minnesota
United States Mayo Clinic Cancer Center Rochester Minnesota
United States Seton Cancer Institute at Saint Mary's - Saginaw Saginaw Michigan
United States Lakeland Regional Cancer Care Center - St. Joseph Saint Joseph Michigan
United States Lakeside Cancer Specialists, PLLC Saint Joseph Michigan
United States Missouri Baptist Cancer Center Saint Louis Missouri
United States CCOP - Metro-Minnesota Saint Louis Park Minnesota
United States Park Nicollet Cancer Center Saint Louis Park Minnesota
United States Regions Hospital Cancer Care Center Saint Paul Minnesota
United States United Hospital Saint Paul Minnesota
United States Cancer Center of Kansas, PA - Salina Salina Kansas
United States Mayo Clinic Scottsdale Scottsdale Arizona
United States Cancer Centers of the Carolinas - Seneca Seneca South Carolina
United States St. Francis Cancer Center at St. Francis Medical Center Shakopee Minnesota
United States St. Nicholas Hospital Sheboygan Wisconsin
United States Mercy Medical Center - Sioux City Sioux City Iowa
United States Siouxland Hematology-Oncology Associates, LLP Sioux City Iowa
United States St. Luke's Regional Medical Center Sioux City Iowa
United States Avera Cancer Institute Sioux Falls South Dakota
United States Sanford Cancer Center at Sanford USD Medical Center Sioux Falls South Dakota
United States CCOP - Northern Indiana CR Consortium South Bend Indiana
United States Memorial Hospital of South Bend South Bend Indiana
United States Cancer Centers of the Carolinas - Spartanburg Spartanburg South Carolina
United States CCOP - Upstate Carolina Spartanburg South Carolina
United States Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Spartanburg South Carolina
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 Iredell Memorial Hospital Statesville North Carolina
United States Marshfield Clinic at Saint Michael's Hospital Stevens Point Wisconsin
United States Saint Michael's Hospital Cancer Center Stevens Point Wisconsin
United States Lakeview Hospital Stillwater Minnesota
United States Door County Cancer Center at Door County Memorial Hospital Sturgeon Bay Wisconsin
United States Flower Hospital Cancer Center Sylvania Ohio
United States North Suburban Medical Center Thornton Colorado
United States Mercy Hospital of Tiffin Tiffin Ohio
United States Medical University of Ohio Cancer Center Toledo Ohio
United States St. Anne Mercy Hospital 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 UVMC Cancer Care Center at Upper Valley Medical Center Troy Ohio
United States Legacy Meridian Park Hospital Tualatin Oregon
United States Natalie Warren Bryant Cancer Center at St. Francis Hospital Tulsa Oklahoma
United States CCOP - Carle Cancer Center Urbana Illinois
United States Legacy Salmon Creek Medical 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 Fulton County Health Center Wauseon Ohio
United States Cancer Center of Kansas, PA - Wellington Wellington Kansas
United States Methodist West Hospital West Des Moines Iowa
United States Mount Carmel St. Ann's Cancer Center Westerville Ohio
United States Marshfield Clinic - Weston Center Weston Wisconsin
United States Ministry Saint Clare's Hospital Weston Wisconsin
United States Michiana Hematology Oncology PC - La Porte Westville Indiana
United States Exempla Lutheran Medical Center Wheat Ridge Colorado
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 Willmar Cancer Center at Rice Memorial Hospital Willmar Minnesota
United States Cancer Center of Kansas, PA - Winfield Winfield Kansas
United States Minnesota Oncology - Woodbury Woodbury Minnesota
United States Ruth G. McMillan Cancer Center at Greene Memorial Hospital Xenia Ohio
United States Genesis - Good Samaritan Hospital Zanesville Ohio

Sponsors (2)

Lead Sponsor Collaborator
Alliance for Clinical Trials in Oncology National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximum Severity of Diarrhea Toxicity as Measured by the CTCAE v4.0 During and After Radiotherapy (RT) The primary endpoint for this study is the maximal severity of diarrhea toxicity. Severity of diarrhea was graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 4.0. Grade 0 = None; 1=Mild; Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening as measured by the CTCAE version 4.0. Assessments were recorded during the course of RT and for 6 weeks following RT. The table below represents the worst graded diarrhea for each patient.
A two-sided Wilcoxon rank-sum test will be used to test the equality of the distributions of maximum diarrhea severity grades between the two treatment arms.
During radiation therapy and up to 6 weeks post radiation therapy
Secondary Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT The maximal severity of each of 5 different adverse even types (Tenesmus, Abdominal Pain, Constipation, Diarrhea, and Rectal Bleeding) were collected as a secondary endpoint. Severity of the events was graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 4.0. Grade 0 = None; 1=Mild; Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening. Adverse events were assessed during the course of RT and for 6 weeks following RT. The table below represents the worst grade for each patient for each type.
Two-sided chi-square tests will be used to compare each percentage variable between treatment arms for each event type.
During radiation therapy and up to 6 weeks post radiation therapy
Secondary Area Under the Curve That Combines the Individual Severity of Diarrhea Toxicity as Measured by the CTCAE v4.0 During and After RT For each patient, an Area Under the Curve (AUC) summary statistic will be calculated taking into account the individual severity of diarrhea toxicity over time. Severity of diarrhea was graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 4.0. Grade 0 = None; 1=Mild; Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening. The curve was constructed using weekly assessments during and after RT. A separate analysis was done during the course of RT and every week for 6 weeks following RT. During radiation therapy and up to 6 weeks post radiation therapy
Secondary Average Graded Severity for Tenesmus, Abdominal Pain, Constipation, Diarrhea and Hemorrhage During and After RT as Graded by CTCAE v4.0 Tenesmus, Abdominal pain, constipation, diarrhea and hemorrhaging were assessed during RT and up to 6 weeks after RT. Severity of these events were graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 4.0. Grade 0 = None; 1=Mild; Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening. For each patient, an average score for each outcome variable during and after RT calculated as follows: The sum of all severity scores for that variable divided by the number of severity scores for that variable recorded for the patient during the course of RT and for 6 weeks following RT. During radiation therapy and up to 6 weeks post radiation therapy
Secondary Percentage of Patients in Each Arm That Experience Tenesmus, Abdominal Pain, Constipation, Diarrhea and Rectal Bleeding During and After RT The number of patients that reported any grade 1 or higher adverse event was divided by the total number of patients evaluated. The analysis was done separately for each of the 5 outcomes and separately during RT and after RT. During radiation therapy and up to 6 weeks post radiation therapy
Secondary Percent of Patients in Each Arm That Recorded "Yes" to Each of Questions 2-10 on the Bowel Function Questionnaire Questions that were used in this analysis:
2. Have you had a problem causing you to get up at night to have a bowel movement? 3. Have you had a problem causing you to lose control of your bowel movements? 4. Have you had a problem causing you to have a bowel movement within 30 minutes of a prior bowel movement? 5. Have you had to wear protective clothing or a pad in case you lost control of a bowel movement? 6. Have you had a problem causing you to be unable to tell the difference between stool and gas? 7. Have you had a problem causing you to have stools that are liquid? 1=yes 2=no q08 8. Have you found that once you feel the urge to have a bowel movement, you must do so within 15 minutes to avoid an accident? 9. Have you had cramping with a bowel movement? 10. Have you had blood in your bowel movement?
Up to 6 weeks post radiation therapy
Secondary Percentage of Patients in Each Arm That Require Any Type of Antidiarrheal Medications. The number of patients reporting the use of anti-diarrheal medications divided by the number of patients evaluated for this endpoint. Up to 24 months post radiotherapy
Secondary Percentage of Patients in Each Arm That Experience Clinically Significant Deficits in Overall Quality of Life and Fatigue For each arm, the percentage of patients experience clinically significant deficits in overall QOL and fatigue as indicated by a score of 5 or lower on the 0-10 scale. The analysis was done using the questionnaire that was completed during the first week of radiotherapy (RT) and 6 weeks after RT. Up to 6 weeks post radiotherapy
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