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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00075868
Recruitment Status : Completed
First Posted : January 13, 2004
Last Update Posted : November 17, 2015
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Radiation Therapy Oncology Group

Study Description
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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.


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

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 233 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

Arms and Interventions
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Arm Intervention/treatment
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)
 Other: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Prevention of the incidence of moderate, severe, or life-threatening diarrhea

Secondary Outcome Measures :
  1. Quality of life
  2. Economic measures
  3. 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
  4. Prevention of the incidence of severe or life-threatening (i.e., grade 3-5) diarrhea

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Sponsors and Collaborators
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
Investigators
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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
More Information
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Publications of Results:
Zachariah B, James J, Gwede CK, et al.: RTOG 0315: a randomized, double-blind, placebo-controlled phase III study to determine the efficacy of octreotide acetate in preventing or reducing the severity of chemoradiation-induced diarrhea in patients with anal or rectal cancer. [Abstract] J Clin Oncol 25 (Suppl 18): A-4032, 2007.

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Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00075868    
Other Study ID Numbers: RTOG-0315
CDR0000349441
First Posted: January 13, 2004    Key Record Dates
Last Update Posted: November 17, 2015
Last Verified: November 2015
Keywords provided by Radiation Therapy Oncology Group:
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
Additional relevant MeSH terms:
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Rectal Neoplasms
Anus Neoplasms
Enteritis
Diarrhea
Drug-Related Side Effects and Adverse Reactions
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
 Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Anus Diseases
Chemically-Induced Disorders
Gastroenteritis
Octreotide
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents