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Pentosan Polysulfate in Treating Patients With Gastrointestinal Disturbance Caused by Radiation Therapy

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00003825
First received: November 1, 1999
Last updated: August 9, 2013
Last verified: August 2013
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Supportive Care
Official Title: Phase III Study of Pentosanpolysulfate (PPS) in Treatment of GI Tract Sequelae of Radiotherapy

Resource links provided by NLM:


Further study details as provided by Radiation Therapy Oncology Group:

Estimated Enrollment: 174
Study Start Date: June 1999
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Detailed Description:

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
Criteria

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
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: NCT00003825

  Show 260 Study Locations
Sponsors and Collaborators
Radiation Therapy Oncology Group
Investigators
Study Chair: Miljenko V. Pilepich, MD Saint Joseph Mercy Cancer Center
  More Information

Additional Information:
Publications:
Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00003825     History of Changes
Other Study ID Numbers: RTOG-9809, CDR0000066979, RTOG-DEV-1016
Study First Received: November 1, 1999
Last Updated: August 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Radiation Therapy Oncology Group:
radiation enteritis
diarrhea

Additional relevant MeSH terms:
Diarrhea
Enteritis
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Intestinal Diseases
Signs and Symptoms
Signs and Symptoms, Digestive
Pentosan Sulfuric Polyester
Anticoagulants
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014