External Beam Radiotherapy for Muscle Invasive Bladder Cancer

Toxicity Clinical Trial

Official title:

Muscle Invasive Bladder Cancer: External Beam Radiotherapy as an Alternative for Cystectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02748200
• Other study ID #: 2015/0169
• Status: Completed
• Phase: Phase 1
• Start date: August 2014
• Est. completion date: October 2020

Study information

• Verified date: December 2022
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: October 2020
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Toxicity
• Urinary Bladder Neoplasms

Intervention

Radiation:
• external beam radiotherapy (EBRT)
EBRT: 3 dose escalation levels

Locations

Country	Name	City	State
Belgium	Ghent University Hospital	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with treatment-related adverse events as assessed by Radiation Therapy Oncology Group toxicity scale		3 months after radiotherapy
Secondary	Number of participants free from local relapse assessed on cystoscopy and Magnetic Resonance Imaging		12 months after radiotherapy