NCT Number: NCT01762527
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Department of Oncology, Aarhus University Hospital, Aarhus, Denmark
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
Time frame: spring 2013
CineMR (time resolved MR) is performed pre-treatment and weekly during RT for the first 10 patients
Time frame: autum 2014
The gain of normal tissue sparring will be calculated using dose accumulation
Time frame: 2015
1 or 2 years disease free survival will be calculated
University of Aarhus
Other
Adaptive Radiotherapy Using Plan Selection for Bladder Cancer: A Phase II Trial
Acronym: plan selection
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT01352962
Adnexal Diseases, Bronchial Neoplasms
Bethesda, Maryland, United States
View Trial DetailsNCT03924856
Bladder Cancer, Female Urogenital Diseases
La Jolla, California, United States
View Trial DetailsNCT04081246
Bladder Cancer, Bladder Neoplasm
Hong Kong
View Trial DetailsNCT05512377
Biliary Tract Cancer, Biliary Tract Diseases
Mobile, Alabama, United States
View Trial Details