Completed

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

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What is being tested

octreotide acetate

+ Placebo
Drug
Other
Who is being recruted

Anus Diseases
+16

+ Anus Neoplasms
+ Diarrhea
From 18 to 120 Years
See all eligibility criteria
How is the trial designed

Supportive Care Study

Placebo-Controlled
Phase 3
Interventional
Study Start: December 2003
See protocol details

Summary

Principal SponsorRadiation Therapy Oncology Group
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: December 1, 2003Actual date on which the first participant was enrolled.

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.

Official TitleA 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 
NCT00075868
Principal SponsorRadiation Therapy Oncology Group
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
233 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Supportive Care Study
These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

None (Single-arm trial)
: If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment
: Everyone gets the same treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a placebo-controlled study, some participants receive the experimental treatment, while others receive an inert substance (placebo) to compare outcomes. This method helps to isolate the effect of the treatment from the psychological effects of receiving any treatment at all.

Other Options
Non-placebo-controlled
: No placebo is used. All participants receive the actual treatment or alternative interventions (often the Standard of Care), and comparisons are made between these treatments.

How the interventions assigned to participants is kept confidential
Neither participants nor researchers know who is receiving which treatment. This is the most rigorous way to reduce bias, ensuring that expectations do not influence the results.

Other Ways to Mask Information
Open-label
: Everyone knows which treatment is being given.

Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 120 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Anus Diseases
Anus Neoplasms
Diarrhea
Digestive System Diseases
Digestive System Neoplasms
Enteritis
Gastroenteritis
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases
Rectal Neoplasms
Signs and Symptoms, Digestive
Colorectal Neoplasms
Chemically-Induced Disorders
Drug-Related Side Effects and Adverse Reactions
Criteria

DISEASE CHARACTERISTICS: * Histologically confirmed primary anal or rectal cancer * No metastasis beyond the pelvic regional nodes * Must be scheduled to receive chemoradiotherapy PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Not specified Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Liver function tests \< 3 times upper limit of normal * No prior hepatic disease Renal * Not specified Gastrointestinal * No prior chronic or acute regional enteritis * No malabsorption syndrome * No prior inflammatory bowel disease that may exacerbate the radiotherapy toxicity * No grade 2 or greater uncontrollable diarrhea at baseline * No prior cholecystitis or gallstones, unless a cholecystectomy has been performed * No prior incontinence of stool Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * HIV negative * No uncontrolled diabetes (e.g., fasting glucose \> 250 mg/dL) * No prior allergy or hypersensitivity to study drug or other related drug or compound * No other medical condition or mental impairment that would preclude study treatment and compliance PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * See Disease Characteristics * Prior chemotherapy allowed Endocrine therapy * At least 6 months since prior administration of any of the following: * Glucocorticoid therapy * Insulin sensitizers (e.g., metformin, pioglitazone, or rosiglitazone) * Exogenous growth hormone therapy Radiotherapy * See Disease Characteristics * No prior pelvic radiotherapy * No prior intensity-modulated radiotherapy * No concurrent radiotherapy for abdominal cancer * No concurrent hyperfractionated, split-course, or intensity-modulated radiotherapy * No brachytherapy prior to or after completion of all external beam radiotherapy Surgery * No prior abdominal-perineal resection or other surgical procedure leaving the patient without a functioning rectum * No colostomy Other * More than 30 days since other prior investigational drugs * No prior octreotide for cancer therapy-related diarrhea * No concurrent prophylactic antidiarrheal medication


Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

50% chance 

of being blinded to the placebo group

Treatment Groups
Group I
Experimental
Sandostatin LAR® Depot Pre-RT (between day -7 and day -4 of RT) and Day 22 (± 3 days)

Group II
Placebo
Placebo Pre-RT (between day -7 and day -4 of RT) and Day 22 (± 3 days)

Study Objectives
Primary Objectives

Secondary Objectives


Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 112 locations
Suspended
Mobile Infirmary Medical CenterMobile, United StatesSee the location
Suspended
Foundation for Cancer Research and EducationPhoenix, United States
Suspended
Enloe Cancer Center at Enloe Medical CenterChico, United States
Suspended
Saint Agnes Medical CenterFresno, United States

Completed112 Study Centers
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