A Phase 3 interventional study of pentosan polysulfate sodium and quality-of-life assessment in Diarrhea and Radiation Enteritis, sponsored by Radiation Therapy Oncology Group. Completed at 260 sites in 2 countries. Open to participants aged 0 Years to 120 Years. Per ClinicalTrials.gov, last updated 2020-10-19.
Sponsored by Radiation Therapy Oncology Group · Phase 3, Interventional, and Supportive care
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.
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.
877 studies on the registry are indexed under Diarrhea; 76 are open to participants now.
This study's planned enrollment of 174 is above the median of 137 across 738 interventional studies indexed under Diarrhea.
Browse Diarrhea studies →Radiation Therapy Oncology Group is the lead sponsor of 155 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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 : 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)
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Showing the first 100 of 260 sites across 2 countries. Choose a country and city above to see the rest.
The record gives a start of Jun 1999 and a primary completion of Apr 2006. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Pentosan Sulfuric Polyester
Radiation Therapy Oncology Group →