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Sponsors and Collaborators: |
North Central Cancer Treatment Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00033605 |
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 |
---|---|---|
Cancer-Related Problem/Condition Cervical Cancer Colorectal Cancer Endometrial Cancer Fallopian Tube Cancer Ovarian Cancer Prostate Cancer Sarcoma Unspecified Adult Solid Tumor, Protocol Specific Vaginal Cancer Vulvar Cancer |
Drug: octreotide acetate |
Phase III |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Double-Blind, Placebo Control |
Official Title: | Phase III Double-Blind Study Of Depot Octreotide Versus Placebo In The Prevention Of Acute Diarrhea In Patients Receiving Pelvic Radiation Therapy |
Study Start Date: | April 2002 |
Primary Completion Date: | July 2006 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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.
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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)
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Study ID Numbers: | CDR0000069304, NCCTG-N00CA, NCI-P02-0221 |
Study First Received: | April 9, 2002 |
Last Updated: | October 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00033605 |
Health Authority: | United States: Federal Government |
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 IV 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 II prostate cancer stage III prostate cancer stage IV prostate cancer unspecified adult solid tumor, protocol specific |
Signs and Symptoms, Digestive Prostatic Diseases Rectal Neoplasms Malignant mesenchymal tumor Colonic Diseases Octreotide Urogenital Neoplasms Vaginal Diseases Ovarian epithelial cancer Rectal Diseases Neoplasms, Connective and Soft Tissue Endometrial Neoplasms Rectal cancer Endocrine Gland Neoplasms Vaginal Neoplasms |
Digestive System Neoplasms Diarrhea Genital Neoplasms, Female Endocrine System Diseases Vaginal cancer Genital Diseases, Male Carcinoma Sarcoma Gastrointestinal Neoplasms Uterine sarcoma Prostatic Neoplasms Genital Neoplasms, Male Gastrointestinal Diseases Gonadal Disorders Ovarian Diseases |
Neoplasms Neoplasms by Histologic Type Neoplasms by Site Antineoplastic Agents, Hormonal Antineoplastic Agents |
Therapeutic Uses Gastrointestinal Agents Pharmacologic Actions Adnexal Diseases |