Phase III, Randomized, Study of Sulfasalazine Versus Placebo in the Prevention of Acute Diarrhea in Patients Receiving Pelvic Radiation Therapy
Phase III, Randomized, Study of Sulfasalazine Versus Placebo in the Prevention of Acute Diarrhea in Patients Receiving Pelvic Radiation Therapy
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.
OBJECTIVES:
Primary
Secondary
Tertiary
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.
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.
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
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)*
Planned treatment is to be given 4-5 times per week on a one-treatment-per-day basis
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:
PRIOR CONCURRENT THERAPY:
Hartford, Connecticut 06105, United States
Boise, Idaho 83706, United States
Moline, Illinois 61265, United States
Des Moines, Iowa 50309, United States
Des Moines, Iowa 50314, United States
Wichita, Kansas 67214, United States
Dearborn, Michigan 48123-2500, United States
Grosse Pointe Woods, Michigan 48236, United States
Minneapolis, Minnesota 55407, United States
Robbinsdale, Minnesota 55422-2900, United States
Billings, Montana 59102, United States
Missoula, Montana 59807, United States
Concord, New Hampshire 03301, United States
Voorhees Township, New Jersey 08043, United States
Greensboro, North Carolina 27403-1198, United States
Columbus, Ohio 43210-1240, United States
Spartanburg, South Carolina 29303, United States
Sioux Falls, South Dakota 57117-5039, United States
Kingsport, Tennessee 37662, United States
Martinsville, Virginia 24115, United States
Huntington, West Virginia 25701, United States
Eau Claire, Wisconsin 54701, United States
Green Bay, Wisconsin 54301-3526, United States
Manitowoc, Wisconsin 54221-1450, United States
Sturgeon Bay, Wisconsin 54235-1495, United States