Spots Global Cancer Trial Database for Radiation and Durvalumab Immunotherapy As Neoadjuvant Treatment for MIBC
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Trial Identification
Brief Title: Radiation and Durvalumab Immunotherapy As Neoadjuvant Treatment for MIBC
Official Title: Neoadjuvant Immune-Modulating Radiation With Durvalumab (MEDI4736) Prior to Radical Cystectomy in Patients With Muscle-Invasive Bladder Carcinoma (RADIANT)
Study ID: NCT04543110
Conditions
Study Description
Brief Summary: This study assesses the effect of sequential radiation and durvalumab immunotherapy given as treatment prior to surgery with radical cystectomy for bladder cancer.
Detailed Description: In this phase II study, patients who are either not eligible or declined to have chemotherapy prior to surgery for muscle-invasive bladder cancer may consent and enrol to study. Patients will have single 8 Gy hypofractionated radiation to bladder followed by 3 cycles of durvalumab immunotherapy prior to radical cystectomy. This study will assess the safety and tolerability, pathological and radiological response, and immune biological correlatives to understand the effect of radiation and durvalumab.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Cross Cancer Institute, Edmonton, Alberta, Canada
Juravinski Cancer Centre, Hamilton, Ontario, Canada
London Health Sciences Centre, London, Ontario, Canada
The Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada
Contact Details
Name: Michael Ong, MD
Affiliation: Ottawa Hospital Research Institute
Role: PRINCIPAL_INVESTIGATOR
Name: Naveen Basappa, MD
Affiliation: Cross Cancer Institute
Role: PRINCIPAL_INVESTIGATOR
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