NCT03333356

Adjuvant Radiotherapy in Patients With Pathological High-risk Bladder Cancer (GETUG-AFU 30)

Adjuvant Radiotherapy in Patients With Pathological High-risk Bladder Cancer: A Randomized Multicentre Phase II Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: UNICANCER · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• Patients With High-risk MIBC

Interventions

Type	Name	Description
RADIATION	pelvic radiotherapy	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).

Timeline

• Start date: 2018-04-19
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2017-11-06
• Last updated: 2024-12-04

Locations

17 sites across 1 country: France