MedDataX Logo

External Beam Radiotherapy for Muscle Invasive Bladder Cancer

NCT ID: NCT02748200

Last Updated: 2022-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2020-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Toxicity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

All patients receive pelvic EBRT to the lymph nodes located along the common, internal, and external iliac artery; obturator fossa; and presacral nodes.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

external beam radiotherapy: Dose level 1

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

Group Type EXPERIMENTAL

external beam radiotherapy (EBRT)

Intervention Type RADIATION

EBRT: 3 dose escalation levels

external beam radiotherapy: dose level 2

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

Group Type EXPERIMENTAL

external beam radiotherapy (EBRT)

Intervention Type RADIATION

EBRT: 3 dose escalation levels

external beam radiotherapy: dose level 3

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

Group Type EXPERIMENTAL

external beam radiotherapy (EBRT)

Intervention Type RADIATION

EBRT: 3 dose escalation levels

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

external beam radiotherapy (EBRT)

EBRT: 3 dose escalation levels

Intervention Type RADIATION

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Valérie Fonteyne, MD; PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ghent University Hospital

Ghent, , Belgium

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Belgium

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2015/0169

Identifier Type: -

Identifier Source: org_study_id