Phase III Double-Blind Study Of Depot Octreotide Versus Placebo In The Prevention Of Acute Diarrhea In Patients Receiving Pelvic Radiation Therapy
- Determine the effectiveness of octreotide in reducing acute treatment-related diarrhea
in patients receiving external-beam radiotherapy to the pelvis.
- Determine the effectiveness of this drug in reducing chronic treatment-related bowel
dysfunction in these patients.
- Determine the toxicity of this drug in these patients.
- Assess the importance that these patients attach to various measures of bowel function.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
are stratified according to prior anterior resection of the rectum (yes vs no), total
planned cumulative dose of radiotherapy, including boost fields (4,500-5,350 cGy vs
5,351-6,000 cGy vs more than 6,000 cGy), use of concurrent fluorouracil (none vs bolus vs
continuous infusion), use of concurrent leucovorin calcium (yes vs no), use of concurrent
cisplatin (yes vs no), superior border of initial field (at or inferior to the L4-5
interspace vs superior to the L4-5 interspace), planned intracavitary brachytherapy (yes vs
no), and primary site of disease (rectal cancer vs prostate cancer vs gynecological cancer
vs other). Beginning no later than the fourth day of radiotherapy, patients are randomized
to one of two treatment arms.
- Arm I: Patients receive short-acting octreotide subcutaneously (SC) on day 1 and
long-acting octreotide intramuscularly (IM) on days 2 and 29.
- Arm II: Patients receive placebo SC on day 1 and IM on days 2 and 29. In both arms,
treatment continues in the absence of unacceptable toxicity or the development of
Patients complete a bowel function questionnaire at baseline, weekly during radiotherapy,
and then weekly for 4 weeks and at 1 and 2 years after completion of radiotherapy.
Patients are followed weekly for 4 weeks and then at 1 and 2 years.
PROJECTED ACCRUAL: A minimum of 125 patients (62 per treatment arm) will be accrued for this
study within 38 months.
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
Reduction of diarrhea as measured by NCI CTC version 2.0 weekly during pelvic radiotherapy
James A. Martenson, MD
United States: Federal Government