Octreotide in Preventing or Reducing Diarrhea in Patients Receiving Chemoradiotherapy for Anal or Rectal Cancer
NCT00075868 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 233
Last updated 2015-11-17
Summary
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.
Conditions
- Anal Cancer
- Colorectal Cancer
- Drug/Agent Toxicity by Tissue/Organ
- Radiation Enteritis
Interventions
- DRUG
-
octreotide acetate
- OTHER
-
Placebo
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
Radiation Therapy Oncology Group
lead NETWORK
Principal Investigators
-
Babu Zachariah, MD · H. Lee Moffitt Cancer Center and Research Institute
-
Jaffer A. Ajani, MD · M.D. Anderson Cancer Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 120 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2003-12-31
- Primary Completion
- 2006-08-31
Countries
- United States
Study Locations
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