Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
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
- 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.
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