NCT01198145

Sulfasalazine in Preventing Acute Diarrhea in Patients With Cancer Who Are Undergoing Pelvic Radiation Therapy

Phase III, Randomized, Study of Sulfasalazine Versus Placebo in the Prevention of Acute Diarrhea in Patients Receiving Pelvic Radiation Therapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Diarrhea
• Gastrointestinal Complications
• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	sulfasalazine	Given orally
OTHER	placebo	Given orally

Timeline

• Start date: 2011-04-01
• Primary completion: 2013-07-22
• Completion: 2017-07-15
• First posted: 2010-09-09
• Last updated: 2020-05-12
• Results posted: 2017-04-04

Locations

257 sites across 1 country: United States