External Beam Radiotherapy for Muscle Invasive Bladder Cancer

Ghent University Hospital (UZ)

Status and phase: Completed; Phase 1

Conditions: Toxicity

Treatments: Radiation: external beam radiotherapy (EBRT)

Study type: Interventional

Funder types: Other

Identifiers

NCT02748200

2015/0169

Details and patient eligibility

About

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.

Full 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.

Enrollment: 77 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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77 participants in 3 patient groups

external beam radiotherapy: Dose level 1

Experimental group

Description:

57.6 Gray (Gy) (20 x 2.88 Gy, 5 fractions/week, 4 weeks)

Treatment:

Radiation: external beam radiotherapy (EBRT)

external beam radiotherapy: dose level 2

Experimental group

Description:

60 Gy (20 x 3.00 Gy, 5 fractions/week, 4 weeks)

Treatment:

Radiation: external beam radiotherapy (EBRT)

external beam radiotherapy: dose level 3

Experimental group

Description:

62.4 Gy (20 x 3.12Gy, 5 fractions/week, 4 weeks)

Treatment:

Radiation: external beam radiotherapy (EBRT)