Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-24 @ 11:28 PM
NCT ID:
NCT03333356
Brief 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).
Study:
NCT03333356
Study Brief:
Protocol Section:
NCT03333356