This trial is active, not recruiting.

Condition adverse effects for adaptive rt of bladder cancer
Treatment adaptive radiotherapy
Phase phase 2
Sponsor University of Aarhus
Collaborator Copenhagen University Hospital at Herlev
Start date October 2012
End date October 2016
Trial size 65 participants
Trial identifier NCT01762527, AUH-KFE-1217, jr.nr. 1-16-02-283-12


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Online adaptive radiotherapy
adaptive radiotherapy Online Adaptive RT using plan selection
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

Primary Outcomes

Gastro- Intestinal toxicity
time frame: Up to 2 years after ART

Secondary Outcomes

Intra-fractional changes of bladder shape and size
time frame: spring 2013
Difference in accumulated dose to normal tissue
time frame: autum 2014
1 or 2 years disease free survival
time frame: 2015

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Adaptive Radiotherapy Using Plan Selection for Bladder Cancer: A Phase II Trial
Principal investigator Morten Høyer, MD, Professor
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of Aarhus.