External Beam Radiotherapy for Muscle Invasive Bladder Cancer

Phase 1

Completed

• Conditions: Toxicity
• Interventions: Radiation: external beam radiotherapy (EBRT)

• Registration Number: NCT02748200
• Lead Sponsor: University Hospital, Ghent

Brief Summary

In this phase 1 trial, the investigators will prospectively evaluate 3 different external beam radiotherapy (EBRT) schedules. In every schedule, the whole bladder will be treated to 40 Gray (Gy) in 20 fractions, 5 fractions/week, 4 weeks in total. Based on the summation of abnormalities seen on pre- (initial tumor region) and post transurethral resection zone of fibrosis Diffusion weighted-magnetic resonance imaging (MRI) images the tumor region is delineated and defined as a gross tumor volume (GTV). The GTV will be treated using a simultaneous integrated boost (SIB): without extending the 4-weeks treatment period, 3 different dose levels will be implemented in order to increase the biological equivalent dose (BED), as muscle invasive bladder cancer has been shown to be dose-sensitive.

Detailed Description

3 different dose levels will be implemented in order to increase the biological equivalent dose (BED), as muscle invasive bladder cancer has been shown to be dose-sensitive.

* Level 1: 57.6 Gray (Gy) (20 x 2.88 Gy, 5 fractions/week, 4 weeks); BED: 61 Gy.

* Level 2: 60 Gy (20 x 3.00 Gy, 5 fractions/week, 4 weeks); BED: 64 Gy

* Level 3: 62.4 Gy (20 x 3.12Gy, 5 fractions/week, 4 weeks); BED: 67 Gy. Fiducials will be implanted at the edges of the postoperative bed during the second transurethral resection of the bladder to improve visualization of the gross tumor volume (GTV) during external beam radiotherapy (EBRT) and consequently improve treatment delivery accuracy. In order to further improve the treatment accuracy, 5 planning Computed Tomographies and plans, with different bladder fillings will be made upfront in our study. During treatment the plan corresponding best with bladder filling at time of EBRT will be selected and delivered.

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2015-03-18
• Study First Submitted QC: 2016-04-19
• Study First Posted: 2016-04-22
• Primary Completion: 2020-10
• Study Completion: 2020-10
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-22
• Last Update Posted: 2022-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

Inclusion Criteria

• histological proven diagnosis of muscle invasive bladder cancer
• stage <T3b tumours with pathological lymph nodes after extended pelvic lymph node dissection
• World Health Organisation performance state 0-2
• signed informed consent

Exclusion Criteria

• contra-indication for Diffusion-Weighted-Magnetic resonance imaging

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
external beam radiotherapy: dose level 2	external beam radiotherapy (EBRT)	60 Gy (20 x 3.00 Gy, 5 fractions/week, 4 weeks)
external beam radiotherapy: dose level 3	external beam radiotherapy (EBRT)	62.4 Gy (20 x 3.12Gy, 5 fractions/week, 4 weeks)
external beam radiotherapy: Dose level 1	external beam radiotherapy (EBRT)	57.6 Gray (Gy) (20 x 2.88 Gy, 5 fractions/week, 4 weeks)

Primary Outcome Measures

Name	Time	Method
Number of participants with treatment-related adverse events as assessed by Radiation Therapy Oncology Group toxicity scale	3 months after radiotherapy

Secondary Outcome Measures

Name	Time	Method
Number of participants free from local relapse assessed on cystoscopy and Magnetic Resonance Imaging	12 months after radiotherapy

Trial Locations

Locations (1)

Ghent University Hospital; 🇧🇪 Ghent, Belgium