Octreotide in Preventing or Reducing Diarrhea in Patients Receiving Chemoradiotherapy for Anal or Rectal Cancer

Phase 3

Completed

• Conditions: Anal Cancer; Colorectal Cancer; Drug/Agent Toxicity by Tissue/Organ; Radiation Enteritis
• Interventions: Drug: octreotide acetate; Other: Placebo

• Registration Number: NCT00075868
• Lead Sponsor: Radiation Therapy Oncology Group

Brief 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.

Detailed Description

OBJECTIVES:

Primary

* 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.

Secondary

* 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 Timeline

• Study Start: 2003-12
• Study First Submitted: 2004-01-09
• Study First Submitted QC: 2004-01-12
• Study First Posted: 2004-01-13
• Primary Completion: 2006-08
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-14
• Last Update Posted: 2015-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 233

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sandostatin LAR® Depot	octreotide acetate	Sandostatin LAR® Depot Pre-RT (between day -7 and day -4 of RT) and Day 22 (± 3 days)
Placebo	Placebo	Placebo Pre-RT (between day -7 and day -4 of RT) and Day 22 (± 3 days)

Primary Outcome Measures

Name	Time	Method
Prevention of the incidence of moderate, severe, or life-threatening diarrhea

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (112)

Mobile Infirmary Medical Center; 🇺🇸 Mobile, Alabama, United States

Foundation for Cancer Research and Education; 🇺🇸 Phoenix, Arizona, United States

Enloe Cancer Center at Enloe Medical Center; 🇺🇸 Chico, California, United States

Saint Agnes Medical Center; 🇺🇸 Fresno, California, United States

California Cancer Center - Woodward Park Office; 🇺🇸 Fresno, California, United States

Sutter Health Western Division Cancer Research Group; 🇺🇸 Greenbrae, California, United States

Cancer Care Consultants Medical Associates at Daniel Freeman Memorial Hospital; 🇺🇸 Inglewood, California, United States

Leavey Cancer Center at Northridge Hospital Medical Center; 🇺🇸 Northridge, California, United States

CCOP - Bay Area Tumor Institute; 🇺🇸 Oakland, California, United States

Pomona Valley Hospital Medical Center; 🇺🇸 Pomona, California, United States

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