Octreotide in Preventing Diarrhea in Patients Who Are Undergoing Radiation Therapy to the Pelvis
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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 |
- Reduction of diarrhea as measured by NCI CTC version 2.0 weekly during pelvic radiotherapy
- 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) |
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 |
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 More Information
Additional Information:
Publications:
| 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:
|
Endometrial Neoplasms Uterine Cervical Neoplasms Colorectal Neoplasms Diarrhea Ovarian Neoplasms Prostatic Neoplasms Vaginal Neoplasms Vulvar Neoplasms Fallopian Tube Neoplasms Adenoma Sarcoma Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site |
Neoplasms Uterine Diseases Genital Diseases, Female Uterine Cervical Diseases Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Signs and Symptoms, Digestive Signs and Symptoms Endocrine Gland Neoplasms |
ClinicalTrials.gov processed this record on June 18, 2013