Patients With High-risk MIBC Clinical Trial
Official title:
Adjuvant Radiotherapy in Patients With Pathological High-risk Bladder Cancer: A Randomized Multicentre Phase II Study
This is a randomized multicentre study in patients with high-risk MIBC to investigate adjuvant radiotherapy after radical cystectomy and pelvic lymph node dissection. The objective of the study is to provide evidence that adjuvant radiotherapy improves loco-regional control with potential benefits in survival. The study will also evaluate the quality of life of patients and the tolerance of the treatment.
INDICATION: Patients with pathological high-risk muscle invasive bladder cancer treated by radical cystectomy and pelvic lymph nodes dissection METHODOLOGY: Multicenter randomised phase II study in high-risk bladder cancer patients treated by radical cystectomy with pelvic lymph nodes dissection assessing : - Experimental Arm: adjuvant pelvic radiotherapy consisting of 28 x 1.8 Gy fractions (total dose of 50.4 Gy), 5 days per week, 1 fraction /day (duration of RT is 38 days). - Standard Arm: surveillance. Eligible patients will be randomised, in a 3:1 ratio, to receive either: adjuvant pelvic radiotherapy (Experimental Arm), or surveillance (Standard Arm). PRIMARY OBJECTIVE: The primary objective of the trial is to assess the efficacy of adjuvant radiotherapy in patients with high-risk bladder cancer after radical cystectomy and pelvic lymph nodes dissection. Efficacy will be assessed in terms of pelvic recurrence-free survival (PRFS) at 3 years. SECONDARY OBJECTIVES: For each treatment arm (adjuvant pelvic radiotherapy [Experimental Arm], or surveillance [Standard Arm]), these objectives will be evaluated independently. - To evaluate 5-year pelvic recurrence-free survival (PRFS) - To evaluate disease-free survival (DFS) at 3 and 5 years. - To evaluate overall survival (OS) at 3 and 5 years. - To evaluate metastasis-free survival (MFS) at 3 and 5 years. - To evaluate disease-specific survival (DSS) at 3 and 5 years. - To evaluate the tolerance and safety of each treatment strategy. - To evaluate patients' quality of life. Ancillary studies Objectives: - Investigation of individual predisposition to develop radiotherapy induced late digestive toxicity using the radiation-induced lymphocyte apoptosis (RILA) assay - The analyse of genomic and transcriptome correlation between different clusters and oncological outcomes - Dosimetric banking to evaluate the correlation of Dose-Volume Histogram with: - Gastrointestinal toxicity grade ≥2; - Pelvic recurrence (radiotherapy volumes, mapping of recurrences). ;