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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00075868
First received: January 9, 2004
Last updated: August 27, 2013
Last verified: August 2013
  Purpose

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 Intervention Phase
Anal Cancer
Colorectal Cancer
Drug/Agent Toxicity by Tissue/Organ
Radiation Enteritis
Drug: octreotide acetate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Radiation Therapy Oncology Group:

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

Secondary Outcome Measures:
  • 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

Enrollment: 233
Study Start Date: December 2003
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00075868

  Show 112 Study Locations
Sponsors and Collaborators
Radiation Therapy Oncology Group
Investigators
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

Additional Information:
Publications:
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.

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00075868     History of Changes
Other Study ID Numbers: RTOG-0315, CDR0000349441
Study First Received: January 9, 2004
Last Updated: August 27, 2013
Health Authority: United States: Food and Drug Administration

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:
Anus Neoplasms
Colorectal Neoplasms
Enteritis
Anus Diseases
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastroenteritis
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases
Rectal Neoplasms
Octreotide
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Gastrointestinal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014