Adjuvant Concurrent Immunotherapy and Radiotherapy for the Treatment of Bladder Cancer
Brief description of study
The primary objective of this Phase I study is to establish the safety of adjuvant concurrent radiation therapy and immunotherapy. Safety will be based on acute grade 3 or higher pelvic radiation related toxicity. Secondary objectives are to estimate late toxicities, quality of life, locoregional and distant failure and overall survival. The primary study endpoint is acute grade 3 or higher pelvic radiation related toxicity. Acute Toxicity is defined as any toxicity observed within 18 weeks from start of radiation therapy. For the purposes of the primary endpoint, a toxicity will be classified as related to pelvic radiation if the toxicity involves or is the result of effects on tissues that are within the 50% isodose bath of the radiation treatment as defined on the radiation treatment planning simulation scan. Toxicities will be graded by CTCAE Version 5.0.
Concurrent adjuvant radiation and immunotherapy will be deemed safe if it is likely (i.e. a posterior probability of 50% or greater) that the acute grade 3 or higher pelvic radiation related toxicity rate is 20%. N/A
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Medical Research
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Age: - 99 Years
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Gender: All
TBD
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