Adaptive Radiotherapy Using Plan Selection for Bladder Cancer
NCT01762527 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 65
Last updated 2021-05-06
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.
Conditions
- Adverse Effects for Adaptive RT of Bladder Cancer
Interventions
- 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
Sponsors & Collaborators
-
Copenhagen University Hospital at Herlev
collaborator OTHER -
Odense University Hospital
collaborator OTHER -
University of Aarhus
lead OTHER
Principal Investigators
-
Morten Høyer, MD, Professor · Aarhus University Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-10-31
- Primary Completion
- 2016-10-30
- Completion
- 2016-10-30
Countries
- Denmark
Study Locations
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