Phase III study of XXXX ( @entity11287 ) in treatment of gastrointestinal tract sequelae of radiotherapy.

@entity1 @entity548 @entity4272 @entity294 @entity1066 @entity11286 @entity11287 @entity476
OBJECTIVES: To evaluate the effectiveness of @entity11286 ( @entity11287 ) in the treatment of gastrointestinal tract sequelae of radiotherapy. METHODS: Eligible @entity1 were those with grade 1 to 3 radiation related @entity4272 , @entity294 and/or @entity476 . At least 4 weeks had to elapse since the completion of the radiotherapy course. @entity1 with @entity548 diathesis or @entity1066 , and patients receiving anticoagulants or chemotherapy were excluded. Stratification criteria included the type of sequelae ( @entity4272 , @entity294 , @entity476 ), the severity grade and the onset (<3 months post-RT, >3 months post-RT). @entity1 were randomized to one of the following arms: 100 mg @entity11287 3 times per day (300 mg/day), 200 mg @entity11287 3 times per day (600 mg/day), or placebo 3 times per day. If there was no improvement in symptoms after 2 months, the protocol treatment was discontinued. If the symptoms improved or resolved, the protocol treatment was continued for additional 4 months. @entity1 under treatment were evaluated monthly, than every 2 to 3 months for the next 18 months. A symptom assessment questionnaire was used to measure quality of life endpoints. RESULTS: From June 1999 to March 2001 180 @entity1 were accessioned from 34 institutions. A total of 168 were analyzable. Neither the best observed response within 3 months for the entire population, nor the response rate within sequelae category or the quality of life measures differed significantly between the 3 arms of the study. CONCLUSION: Administration of @entity11287 has not been associated with an improvement in the clinical course of radiation related morbidity of the gastrointestinal tract.
