Adaptive Radiotherapy Using Plan Selection for Bladder Cancer (plan selection)

May 4, 2021 updated by: University of Aarhus

Adaptive Radiotherapy Using Plan Selection for Bladder Cancer: A Phase II Trial

This protocol describes a Phase 2 clinical trial of online adaptive Radiotherapy, using a library of 3 dose plans corresponding to Small, Medium and Large size bladder. The procedure includes 'Common Toxicity Criteria for Adverse Effects'(CTCAE) for registration of adverse effects (baseline, every 2'nd week during RT, 2 weeks, 3, 6, 12 and 24 month after RT) as well as cineMR for intra-fractional motion (baseline and every week during RT). Patients receive standard non-adaptive RT in the first week. Delineations of the bladder on the Cone-Beam scans (CBCT) from first week of treatment are used for planning the Small and Medium size bladder plans. Large size plan are the standard non-adaptive treatment plan used for the first week of treatment. A margin of 5 mm for intra fractional movement is used.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

After inclusion patients are asked about their adverse effects by an oncologist using CTCAE (version 4.0) questionnaire. A planning CT-scan is acquired and for the first 10 patients also a MR-scan for intra fractional motion is acquired. The MR sequence is repeated every week during radiotherapy. The first week of treatment a standard non-adaptive IMRT-plan is used and CBCT-scans are acquired before and after treatment. The CBCT-scans are used for delineation of the bladder on the CBCT-scans from the first 4 fractions. The adaptive plans are generated from the union of the first 4 CBCT-bladders and the planning CT bladder (medium size) and the volume contained in at least 2 out of the 5 bladder volumes (small size). Details can be found in the reference list. From the 6'Th fraction the treatment is performed using the most appropriate size of treatment plan. CTCAE is repeated every other week during radiotherapy and 2 weeks, 3, 6, 12 and 24 month after radiotherapy.

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000 C
        • Department of Oncology, Aarhus University Hospital
      • Herlev, Denmark, 2730
        • Herlev Hospital
      • Odense, Denmark, 5000
        • Odense University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically proven bladder cancer
  • Age over 18 years
  • Urothelial or planocellular carcinoma
  • Stage T2 T4A
  • Stage N0M0
  • Suitable for radiotherapy
  • ECOG/WHO performance status 0-2

Exclusion Criteria:

  • Suspected or confirmed distant metastases
  • Previous surgery in the small pelvis
  • Inflammatory bowel disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ART
Online adaptive radiotherapy
Radiation: Adaptive Radiotherapy
CTCAE scoring baseline, every 2'nd week during RT, 2 weeks, 3, 12 and 24 month after RT cineMR (time resolved MR) baseline and weekly during RT for intra fractional motion
Other Names:
  • Online Adaptive RT using plan selection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastro- Intestinal toxicity
Time Frame: Up to 2 years after ART
Grade 2 or more GI toxicity using CTCAE 4.0 baseline, every 2'nd week during RT, 2 weeks, 3, 12 and 24 month after RT
Up to 2 years after ART

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intra-fractional changes of bladder shape and size
Time Frame: spring 2013
CineMR (time resolved MR) is performed pre-treatment and weekly during RT for the first 10 patients
spring 2013
Difference in accumulated dose to normal tissue
Time Frame: autum 2014
The gain of normal tissue sparring will be calculated using dose accumulation
autum 2014
1 or 2 years disease free survival
Time Frame: 2015
1 or 2 years disease free survival will be calculated
2015

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Odense University Hospital
Copenhagen University Hospital at Herlev

Investigators

  • Principal Investigator: Morten Høyer, MD, Professor, Aarhus University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2012

Primary Completion (Actual)

October 30, 2016

Study Completion (Actual)

October 30, 2016

Study Registration Dates

First Submitted

January 3, 2013

First Submitted That Met QC Criteria

January 4, 2013

First Posted (Estimate)

January 7, 2013

Study Record Updates

Last Update Posted (Actual)

May 6, 2021

Last Update Submitted That Met QC Criteria

May 4, 2021

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AUH-KFE-1217
  • jr.nr. 1-16-02-283-12 (Other Grant/Funding Number: The Danish National Committee on Health Research Ethics)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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