Adaptive Radiotherapy Using Plan Selection for Bladder Cancer
Conditions
Adverse Effects for Adaptive RT of Bladder Cancer
Conditions: official terms
Urinary Bladder Neoplasms
Conditions: Keywords
Adaptive radiotherapy, Bladder cancer
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Adaptive Radiotherapy
Type: Radiation
Overall Status
Recruiting
Summary
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.
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Locations
Department of Oncology, Aarhus University Hospital
Aarhus, Denmark
Status: Recruiting
Contact: Morten Høyer, MD, PhD, Prof. - +45 7846 2529 - hoyer@aarhus.rm.dk
Herlev Hospital
Herlev, Denmark
Status: Not yet recruiting
Contact: Henriette Lindberg, MD, PhD - +4538689597 - Henriette.Lindberg@regionh.dk
Start Date
October 2012
Completion Date
April 2016
Sponsors
University of Aarhus
Source
University of Aarhus
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page