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External Beam Radiotherapy for Muscle Invasive Bladder Cancer

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ClinicalTrials.gov Identifier: NCT02748200
Recruitment Status : Unknown
Verified April 2016 by Radiotherapie, University Hospital, Ghent.
Recruitment status was:  Recruiting
First Posted : April 22, 2016
Last Update Posted : April 22, 2016
Sponsor:
Information provided by (Responsible Party):
Radiotherapie, University Hospital, Ghent

March 18, 2015
April 22, 2016
April 22, 2016
March 2015
March 2017   (Final data collection date for primary outcome measure)
Number of participants with treatment-related adverse events as assessed by Radiation Therapy Oncology Group toxicity scale [ Time Frame: 3 months after radiotherapy ]
Same as current
No Changes Posted
Number of participants free from local relapse assessed on cystoscopy and Magnetic Resonance Imaging [ Time Frame: 12 months after radiotherapy ]
Same as current
Not Provided
Not Provided
 
External Beam Radiotherapy for Muscle Invasive Bladder Cancer
Muscle Invasive Bladder Cancer: External Beam Radiotherapy as an Alternative for Cystectomy
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.

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.
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Toxicity
Radiation: external beam radiotherapy (EBRT)
EBRT: 3 dose escalation levels
  • Experimental: external beam radiotherapy: Dose level 1
    57.6 Gray (Gy) (20 x 2.88 Gy, 5 fractions/week, 4 weeks)
    Intervention: Radiation: external beam radiotherapy (EBRT)
  • Experimental: external beam radiotherapy: dose level 2
    60 Gy (20 x 3.00 Gy, 5 fractions/week, 4 weeks)
    Intervention: Radiation: external beam radiotherapy (EBRT)
  • Experimental: external beam radiotherapy: dose level 3
    62.4 Gy (20 x 3.12Gy, 5 fractions/week, 4 weeks)
    Intervention: Radiation: external beam radiotherapy (EBRT)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
9
Same as current
May 2017
March 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT02748200
2015/0169
No
Not Provided
Plan to Share IPD: Undecided
Radiotherapie, University Hospital, Ghent
University Hospital, Ghent
Not Provided
Principal Investigator: Valérie Fonteyne, MD; PhD University Hospital, Ghent
University Hospital, Ghent
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP