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| Sponsor: | Radiation Therapy Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003825 |
Purpose
RATIONALE: Pentosan polysulfate may be effective in treating side effects of radiation therapy to the abdomen or pelvis. It is not yet known whether pentosan polysulfate is more effective than no further therapy for treating gastrointestinal disturbance caused by previous radiation therapy.
PURPOSE: Randomized phase III trial to determine the effectiveness of pentosan polysulfate in treating patients who have inflammation of the rectum, diarrhea, or blood in stools caused by previous radiation therapy to the abdomen and pelvis.
| Condition | Intervention | Phase |
|---|---|---|
|
Diarrhea Radiation Enteritis |
Drug: pentosan polysulfate sodium Procedure: quality-of-life assessment |
Phase III |
| Study Type: | Interventional |
| Study Design: | Supportive Care, Randomized |
| Official Title: | Phase III Study of Pentosanpolysulfate (PPS) in Treatment of GI Tract Sequelae of Radiotherapy |
| Estimated Enrollment: | 174 |
| Study Start Date: | June 1999 |
| Primary Completion Date: | April 2006 (Final data collection date for primary outcome measure) |
OBJECTIVES: I. Evaluate the efficacy of pentosan polysulfate in patients with gastrointestinal tract sequelae after radiotherapy to the abdomen and pelvis. II. Determine the toxic effects of this drug in these patients. III. Determine the effect of this drug on symptoms and quality of life of these patients.
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive oral pentosan polysulfate three times a day for 2-6 months. Arm II: Patients receive oral placebo three times a day for 2-6 months. Both arms: Patients may receive retreatment for two months if symptoms return and last for at least 2 weeks. Quality of life is assessed before treatment, and at each follow up visit. Patients are followed every 2 months for 6 months, then every 3 months for 18 months, then annually for 3 years.
PROJECTED ACCRUAL: A total of 174 patients will be accrued for this study within 3 years.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Must have received prior radiotherapy to the abdomen and pelvis and now have radiation related gastrointestinal symptoms (which were not present before the radiotherapy and/or attributed to other causes) Proctitis Diarrhea Melena (blood in stools) Severity of symptoms classified as grade 1, 2, or 3
PATIENT CHARACTERISTICS: Age: Any age Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No bleeding ulcers No bleeding diathesis
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 1 month since prior chemotherapy No concurrent chemotherapy Endocrine therapy: Concurrent hormonal therapy for prostate cancer allowed Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy Surgery: No prior bowel resection At least 3 weeks since prior surgery Other: No concurrent anticoagulation therapy (except aspirin)
Contacts and Locations
Show 260 Study Locations| Study Chair: | Miljenko V. Pilepich, MD | Saint Joseph Mercy Cancer Center |
More Information
| Study ID Numbers: | CDR0000066979, RTOG-9809, RTOG-DEV-1016 |
| Study First Received: | November 1, 1999 |
| Last Updated: | August 19, 2009 |
| ClinicalTrials.gov Identifier: | NCT00003825 History of Changes |
| Health Authority: | United States: Federal Government |
|
radiation enteritis diarrhea |
|
Diarrhea Anticoagulants Signs and Symptoms, Digestive Gastrointestinal Diseases Enteritis Hematologic Agents Intestinal Diseases |
Pharmacologic Actions Signs and Symptoms Digestive System Diseases Therapeutic Uses Gastroenteritis Pentosan Sulfuric Polyester |
