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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

Phase 3
18 Years
Not Enrolling
Anal Cancer, Colorectal Cancer, Drug/Agent Toxicity by Tissue/Organ, Radiation Enteritis

Thank you

Trial Information

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



- 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.

Inclusion Criteria


- Histologically confirmed primary anal or rectal cancer

- No metastasis beyond the pelvic regional nodes

- Must be scheduled to receive chemoradiotherapy



- 18 and over

Performance status

- Not specified

Life expectancy

- Not specified


- Not specified


- Liver function tests < 3 times upper limit of normal

- No prior hepatic disease


- Not specified


- 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


- 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


Biologic therapy

- Not specified


- 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


- 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


- No prior abdominal-perineal resection or other surgical procedure leaving the patient
without a functioning rectum

- No colostomy


- More than 30 days since other prior investigational drugs

- No prior octreotide for cancer therapy-related diarrhea

- No concurrent prophylactic antidiarrheal medication

Type of Study:


Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care

Outcome Measure:

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

Principal Investigator

Babu Zachariah, MD

Investigator Role:

Study Chair

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute


United States: Federal Government

Study ID:




Start Date:

December 2003

Completion Date:

Related Keywords:

  • Anal Cancer
  • Colorectal Cancer
  • Drug/Agent Toxicity by Tissue/Organ
  • Radiation Enteritis
  • radiation enteritis
  • drug/agent toxicity by tissue/organ
  • stage I rectal cancer
  • stage II rectal cancer
  • stage III rectal cancer
  • stage IIIA anal cancer
  • stage IIIB anal cancer
  • recurrent anal cancer
  • stage I anal cancer
  • stage II anal cancer
  • recurrent rectal cancer
  • Anus Neoplasms
  • Rectal Neoplasms
  • Colorectal Neoplasms
  • Enteritis



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