Octreotide in Preventing Diarrhea in Patients Who Are Undergoing Radiation Therapy to the Pelvis

July 12, 2016 updated by: Alliance for Clinical Trials in Oncology

Phase III Double-Blind Study Of Depot Octreotide Versus Placebo In The Prevention Of Acute Diarrhea In Patients Receiving Pelvic Radiation Therapy

RATIONALE: Octreotide may be effective in preventing or controlling diarrhea in patients who are undergoing radiation therapy to the pelvis. It is not yet known whether octreotide is effective for diarrhea.

PURPOSE: Randomized phase III trial to determine the effectiveness of octreotide in preventing diarrhea in patients who are undergoing radiation therapy to the pelvis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine the effectiveness of octreotide in reducing acute treatment-related diarrhea in patients receiving external-beam radiotherapy to the pelvis.
  • Determine the effectiveness of this drug in reducing chronic treatment-related bowel dysfunction in these patients.
  • Determine the toxicity of this drug in these patients.
  • Assess the importance that these patients attach to various measures of bowel function.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to prior anterior resection of the rectum (yes vs no), total planned cumulative dose of radiotherapy, including boost fields (4,500-5,350 cGy vs 5,351-6,000 cGy vs more than 6,000 cGy), use of concurrent fluorouracil (none vs bolus vs continuous infusion), use of concurrent leucovorin calcium (yes vs no), use of concurrent cisplatin (yes vs no), superior border of initial field (at or inferior to the L4-5 interspace vs superior to the L4-5 interspace), planned intracavitary brachytherapy (yes vs no), and primary site of disease (rectal cancer vs prostate cancer vs gynecological cancer vs other). Beginning no later than the fourth day of radiotherapy, patients are randomized to one of two treatment arms.

  • Arm I: Patients receive short-acting octreotide subcutaneously (SC) on day 1 and long-acting octreotide intramuscularly (IM) on days 2 and 29.
  • Arm II: Patients receive placebo SC on day 1 and IM on days 2 and 29. In both arms, treatment continues in the absence of unacceptable toxicity or the development of severe diarrhea.

Patients complete a bowel function questionnaire at baseline, weekly during radiotherapy, and then weekly for 4 weeks and at 1 and 2 years after completion of radiotherapy.

Patients are followed weekly for 4 weeks and then at 1 and 2 years.

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed cancer in the pelvis

  • Plan to receive continuous definitive or adjuvant external-beam radiotherapy to the pelvis or pelvis and para-aortic lymph nodes (total planned dose of 4,500-5,350 cGy)

    • Entire pelvis must be encompassed by planned radiotherapy field (superior border not inferior to the most inferior aspect of sacroiliac joints)
    • Portions of rectum may have special blocking depending on disease site
    • Planned treatment for once-daily radiotherapy 4-5 times a week (planned daily dose 170-210 cGy)
    • No planned split-course radiotherapy
    • No planned interstitial brachytherapy prior to completion of external-beam radiotherapy
    • Planned intracavitary radiotherapy allowed
    • No planned cytotoxic chemotherapy agents concurrently with radiotherapy except fluorouracil with or without leucovorin calcium or cisplatin
    • Entered on study before the third radiotherapy fraction
  • No current or prior metastases beyond pelvic or para-aortic lymph nodes
  • No grade 3 or greater diarrhea, rectal bleeding, or abdominal cramping prior to radiotherapy
  • No incontinence of stool

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Renal:

  • No chronic renal failure
  • Creatinine less than 2 times upper limit of normal (for patients with history of renal disease)

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No known allergy to octreotide
  • No history of inflammatory bowel disease
  • No other concurrent medical condition that would preclude study participation
  • No history of cholecystitis unless prior cholecystectomy

PRIOR CONCURRENT THERAPY:

Radiotherapy:

  • See Disease Characteristics
  • No prior radiotherapy to the pelvis

Surgery:

  • See Disease Characteristics
  • No prior abdominal-perineal resection, Hartmann procedure, or other surgical procedure resulting in non-functioning rectum

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: octreotide + radiation

Patients receive short-acting octreotide subcutaneously (SC) on day 1 and long-acting octreotide intramuscularly (IM) on days 2 and 29.

Treatment continues in the absence of unacceptable toxicity or the development of severe diarrhea.

Patients complete a bowel function questionnaire at baseline, weekly during radiotherapy, and then weekly for 4 weeks and at 1 and 2 years after completion of radiotherapy.

Patients are followed weekly for 4 weeks and then at 1 and 2 years.
Drug: octreotide acetate
Radiation: radiation
Active Comparator: placebo + radiation

Patients receive placebo SC on day 1 and IM on days 2 and 29. Treatment continues in the absence of unacceptable toxicity or the development of severe diarrhea.

Patients complete a bowel function questionnaire at baseline, weekly during radiotherapy, and then weekly for 4 weeks and at 1 and 2 years after completion of radiotherapy.

Patients are followed weekly for 4 weeks and then at 1 and 2 years.
Other: placebo
Radiation: radiation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction of diarrhea as measured by NCI CTC version 2.0 weekly during pelvic radiotherapy
Time Frame: Up to 2 years
Up to 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Reduction of patient-reported bowel dysfunction as assessed by the bowel function questionnaire weekly during radiotherapy, weekly for 4 weeks after radiotherapy, and 12 and 24 months after completion of radiotherapy
Time Frame: Up to 2 years
Up to 2 years
Toxicity as assessed by NCI CTC version 2.0 weekly during pelvic radiotherapy
Time Frame: Up to 2 years
Up to 2 years
Importance that patients attach to various measures of bowel dysfunction as assessed by questionnaire at week 4 of radiotherapy and at 12 and 24 months after completion of radiotherapy
Time Frame: Up to 2 years
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alliance for Clinical Trials in Oncology

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: James A. Martenson, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2002

Primary Completion (Actual)

July 1, 2006

Study Completion (Actual)

July 1, 2006

Study Registration Dates

First Submitted

April 9, 2002

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

July 13, 2016

Last Update Submitted That Met QC Criteria

July 12, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCCTG-N00CA
  • CDR0000069304 (Registry Identifier: PDQ (Physician Data Query))
  • NCI-P02-0221

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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