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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00033605
First received: April 9, 2002
Last updated: September 2, 2012
Last verified: October 2005
  Purpose

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.


Condition Intervention Phase
Cervical Cancer
Colorectal Cancer
Diarrhea
Endometrial Cancer
Fallopian Tube Cancer
Ovarian Cancer
Prostate Cancer
Sarcoma
Unspecified Adult Solid Tumor, Protocol Specific
Vaginal Cancer
Vulvar Cancer
Drug: octreotide acetate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Supportive Care
Official Title: Phase III Double-Blind Study Of Depot Octreotide Versus Placebo In The Prevention Of Acute Diarrhea In Patients Receiving Pelvic Radiation Therapy

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Reduction of diarrhea as measured by NCI CTC version 2.0 weekly during pelvic radiotherapy

Secondary Outcome Measures:
  • 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
  • Toxicity as assessed by NCI CTC version 2.0 weekly during pelvic radiotherapy
  • 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

Study Start Date: April 2002
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
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.

PROJECTED ACCRUAL: A minimum of 125 patients (62 per treatment arm) will be accrued for this study within 38 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

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:

Biologic therapy:

  • Not specified

Chemotherapy:

  • See Disease Characteristics

Endocrine therapy:

  • No other concurrent octreotide

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
  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: NCT00033605

Sponsors and Collaborators
North Central Cancer Treatment Group
Investigators
Study Chair: James A. Martenson, MD Mayo Clinic
  More Information

Additional Information:
Publications:
Martenson JA, Sloan JA, Deming RL, et al.: Phase III double-blind study of depot octreotide versus placebo in the prevention of acute diarrhea during pelvic radiation therapy: results of North Central Cancer Treatment Group protocol N00CA. [Abstract] J Clin Oncol 24 (Suppl 18): A-8506, 469s, 2006.

ClinicalTrials.gov Identifier: NCT00033605     History of Changes
Other Study ID Numbers: CDR0000069304, NCCTG-N00CA, NCI-P02-0221
Study First Received: April 9, 2002
Last Updated: September 2, 2012
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
diarrhea
stage I rectal cancer
stage II rectal cancer
stage III rectal cancer
stage IV rectal cancer
stage III cervical cancer
stage IB cervical cancer
stage IIB cervical cancer
stage IVB cervical cancer
stage IIA cervical cancer
stage IVA cervical cancer
stage I ovarian epithelial cancer
stage II ovarian epithelial cancer
stage III vulvar cancer
stage IVB vulvar cancer
stage 0 vaginal cancer
stage I vaginal cancer
stage II vaginal cancer
stage III vaginal cancer
stage IVA vaginal cancer
stage IVB vaginal cancer
stage I endometrial carcinoma
stage II endometrial carcinoma
stage III endometrial carcinoma
stage IV endometrial carcinoma
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer
stage IV prostate cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Diarrhea
Fallopian Tube Neoplasms
Ovarian Neoplasms
Prostatic Neoplasms
Sarcoma
Uterine Cervical Neoplasms
Vaginal Neoplasms
Vulvar Neoplasms
Adnexal Diseases
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Fallopian Tube Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Genital Diseases, Female
Genital Diseases, Male
Genital Neoplasms, Female
Genital Neoplasms, Male
Gonadal Disorders
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Connective and Soft Tissue
Ovarian Diseases

ClinicalTrials.gov processed this record on October 23, 2014