Octreotide in Preventing or Reducing Diarrhea in Patients Receiving Chemoradiotherapy for Anal or Rectal Cancer
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|ClinicalTrials.gov Identifier: NCT00075868|
Recruitment Status : Completed
First Posted : January 13, 2004
Last Update Posted : November 17, 2015
RATIONALE: Octreotide may be effective in preventing or controlling diarrhea in patients who are undergoing chemoradiotherapy for anal or rectal cancer. It is not yet known whether octreotide is effective in treating diarrhea.
PURPOSE: This randomized phase III trial is studying octreotide in preventing or reducing diarrhea in patients who are undergoing chemoradiotherapy for anal or rectal cancer.
|Condition or disease||Intervention/treatment||Phase|
|Anal Cancer Colorectal Cancer Drug/Agent Toxicity by Tissue/Organ Radiation Enteritis||Drug: octreotide acetate Other: Placebo||Phase 3|
- Determine the ability of octreotide to prevent the incidence of moderate, severe, or life-threatening chemoradiotherapy-induced diarrhea (grades 2-4) in patients with anal or rectal cancer.
- Compare the quality of life of patients treated with this drug vs placebo.
- Compare the number of hospitalizations and use of antidiarrheal agents (e.g., Imodium®) related to diarrhea (or its complications) in patients treated with these drugs.
- Compare treatment delays and/or dose reductions (chemotherapy and radiotherapy) in patients treated with these drugs.
OUTLINE: This is a double-blind, placebo-controlled, randomized, multicenter study. Patients are stratified according to radiotherapy dose (< 50 Gy vs ≥ 50 Gy), chemotherapy dose (bolus vs continuous), and gender. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive octreotide* intramuscularly (IM) 4-7 days before the start of chemoradiotherapy and on day 22 (± 3 days) during chemoradiotherapy.
- Arm II: Patients receive placebo* IM 4-7 days before the start of chemoradiotherapy and on day 22 (± 3 days) during chemoradiotherapy.
NOTE: *Patients receive a total of 2 injections of octreotide or placebo
In both arms, treatment continues in the absence of unacceptable toxicity.
Quality of life is assessed at baseline, at the completion of chemoradiotherapy, and at 3, 6, 9, and 15 months from the start of chemoradiotherapy.
Patients are followed at 3, 6, 9, and 15 months from the start of chemoradiotherapy.
PROJECTED ACCRUAL: A total of 226 patients (113 per treatment arm) will be accrued for this study within 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||233 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Supportive Care|
|Official Title:||A Randomized, Double Blind, Placebo-Controlled Phase III Study To Determine The Efficacy Of Sandostatin LAR® Depot (Octreotide Acetate) In Preventing Or Reducing The Severity Of Chemoradiation-Induced Diarrhea In Patients With Anal Or Rectal Cancer|
|Study Start Date :||December 2003|
|Actual Primary Completion Date :||August 2006|
Experimental: Sandostatin LAR® Depot
Sandostatin LAR® Depot Pre-RT (between day -7 and day -4 of RT) and Day 22 (± 3 days)
Drug: octreotide acetate
Placebo Comparator: Placebo
Placebo Pre-RT (between day -7 and day -4 of RT) and Day 22 (± 3 days)
- Prevention of the incidence of moderate, severe, or life-threatening diarrhea
- Quality of life
- Economic measures
- Validity of the Functional Alterations due to Changes in Elimination-Changes in Bowel Function, the Quality of Life-Radiation Therapy Instrument, and the Expand Prostate Index Composite-Bowel questionnaires
- Prevention of the incidence of severe or life-threatening (i.e., grade 3-5) diarrhea
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00075868
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|Principal Investigator:||Babu Zachariah, MD||H. Lee Moffitt Cancer Center and Research Institute|
|Study Chair:||Jaffer A. Ajani, MD||M.D. Anderson Cancer Center|