Octreotide in Preventing Diarrhea in Patients Who Are Undergoing Radiation Therapy to the Pelvis

• Status: Completed
• Trial end date: 2006-07-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Octreotide may be effective in preventing or controlling diarrhea in patients who are undergoing radiation therapy to the pelvis. It is not yet known whether octreotide is effective for diarrhea.

PURPOSE: Randomized phase III trial to determine the effectiveness of octreotide in preventing diarrhea in patients who are undergoing radiation therapy to the pelvis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alliance for Clinical Trials in Oncology
• Collaborator: National Cancer Institute (NCI)
• Treatments: Octreotide

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed cancer in the pelvis

• Plan to receive continuous definitive or adjuvant external-beam radiotherapy to the pelvis or pelvis and para-aortic lymph nodes (total planned dose of 4,500-5,350 cGy)

• Entire pelvis must be encompassed by planned radiotherapy field (superior border not inferior to the most inferior aspect of sacroiliac joints)

• Portions of rectum may have special blocking depending on disease site

• Planned treatment for once-daily radiotherapy 4-5 times a week (planned daily dose 170-210 cGy)

• No planned split-course radiotherapy

• No planned interstitial brachytherapy prior to completion of external-beam radiotherapy

• Planned intracavitary radiotherapy allowed

• No planned cytotoxic chemotherapy agents concurrently with radiotherapy except fluorouracil with or without leucovorin calcium or cisplatin

• Entered on study before the third radiotherapy fraction

• No current or prior metastases beyond pelvic or para-aortic lymph nodes

• No grade 3 or greater diarrhea, rectal bleeding, or abdominal cramping prior to radiotherapy

• No incontinence of stool

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Renal:

• No chronic renal failure

• Creatinine less than 2 times upper limit of normal (for patients with history of renal disease)

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No known allergy to octreotide

• No history of inflammatory bowel disease

• No other concurrent medical condition that would preclude study participation

• No history of cholecystitis unless prior cholecystectomy

PRIOR CONCURRENT THERAPY:

Radiotherapy:

• See Disease Characteristics

• No prior radiotherapy to the pelvis

Surgery:

• See Disease Characteristics

• No prior abdominal-perineal resection, Hartmann procedure, or other surgical procedure resulting in non-functioning rectum