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Completed

NCT Number: NCT02748200

External Beam Radiotherapy for Muscle Invasive Bladder Cancer

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.

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Key information

Conditions

Toxicity

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Ghent University Hospital

Ghent, 9000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

External beam radiotherapy (EBRT)

Radiation

EBRT: 3 dose escalation levels

Primary outcomes

  1. Number of participants with treatment-related adverse events as assessed by Radiation Therapy Oncology Group toxicity scale

    Time frame: 3 months after radiotherapy

Secondary outcomes

  1. Number of participants free from local relapse assessed on cystoscopy and Magnetic Resonance Imaging

    Time frame: 12 months after radiotherapy

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Apr 22, 2016
Registry last updated
Dec 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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