Clinical trial NCT02748200: External Beam Radiotherapy for Muscle Invasive Bladder Cancer
Official title: Muscle Invasive Bladder Cancer: External Beam Radiotherapy as an Alternative for Cystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Toxicity
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2016-04-22
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All patients receive pelvic EBRT to the lymph nodes located along the common, internal, and external iliac artery; obturator fossa; and presacral nodes.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by Radiation Therapy Oncology Group toxicity scale
timeFrame: 3 months after radiotherapy
Secondary outcomes:
measure: Number of participants free from local relapse assessed on cystoscopy and Magnetic Resonance Imaging
timeFrame: 12 months after radiotherapy
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
Study officials:
affiliation: University Hospital, Ghent
name: Valérie Fonteyne, MD; PhD
role: PRINCIPAL_INVESTIGATOR
References: