External Beam Radiotherapy for Muscle Invasive Bladder Cancer

NCT02748200 | Completed Phase 1

• 1 other identifier: 2015/0169
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

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.

Conditions

Toxicity

Outcome Measures

Primary Outcomes (1)

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

  3 months after radiotherapy

Secondary Outcomes (1)

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

  12 months after radiotherapy

Study Arms (3)

external beam radiotherapy: Dose level 1

EXPERIMENTAL

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

Radiation: external beam radiotherapy (EBRT)

external beam radiotherapy: dose level 2

EXPERIMENTAL

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

Radiation: external beam radiotherapy (EBRT)

external beam radiotherapy: dose level 3

EXPERIMENTAL

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

Radiation: external beam radiotherapy (EBRT)

Interventions

external beam radiotherapy (EBRT) RADIATION

EBRT: 3 dose escalation levels

external beam radiotherapy: Dose level 1; external beam radiotherapy: dose level 2; external beam radiotherapy: dose level 3

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• contra-indication for Diffusion-Weighted-Magnetic resonance imaging

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

Location

Study Officials

• Valérie Fonteyne, MD; PhD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All patients receive pelvic EBRT to the lymph nodes located along the common, internal, and external iliac artery; obturator fossa; and presacral nodes.

Study Record Dates

• First Submitted: March 18, 2015
• First Posted: April 22, 2016
• Study Start: August 1, 2014
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: December 27, 2022

Record last verified: 2022-12

Locations

BE (1)