Clinical trial NCT01762527: Adaptive Radiotherapy Using Plan Selection for Bladder Cancer
Official title: Adaptive Radiotherapy Using Plan Selection for Bladder Cancer: A Phase II Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adverse Effects for Adaptive RT of Bladder Cancer
Keywords: Adaptive radiotherapy
Bladder cancer
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Copenhagen University Hospital at Herlev
name: Odense University Hospital
First posted: 2013-01-07
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Daily adaptation of radiotherapy
Primary purpose: TREATMENT

Brief 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.

Eligibility 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

Primary outcomes:
measure: Gastro- Intestinal toxicity
timeFrame: Up to 2 years after ART
Secondary outcomes:
measure: Intra-fractional changes of bladder shape and size
timeFrame: spring 2013
measure: Difference in accumulated dose to normal tissue
timeFrame: autum 2014
measure: 1 or 2 years disease free survival
timeFrame: 2015
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Oncology, Aarhus University Hospital
city: Herlev
country: Denmark
facility: Herlev Hospital
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Aarhus University Hospital
name: Morten Høyer, MD, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vestergaard A, Sondergaard J, Petersen JB, Hoyer M, Muren LP. A comparison of three different adaptive strategies in image-guided radiotherapy of bladder cancer. Acta Oncol. 2010 Oct;49(7):1069-76. doi: 10.3109/0284186X.2010.501813.
citation: Vestergaard A, Hafeez S, Muren LP, Nill S, Hoyer M, Hansen VN, Gronborg C, Pedersen EM, Petersen JB, Huddart R, Oelfke U. The potential of MRI-guided online adaptive re-optimisation in radiotherapy of urinary bladder cancer. Radiother Oncol. 2016 Jan;118(1):154-9. doi: 10.1016/j.radonc.2015.11.003. Epub 2015 Nov 26.
citation: Vestergaard A, Muren LP, Lindberg H, Jakobsen KL, Petersen JB, Elstrom UV, Agerbaek M, Hoyer M. Normal tissue sparing in a phase II trial on daily adaptive plan selection in radiotherapy for urinary bladder cancer. Acta Oncol. 2014 Aug;53(8):997-1004. doi: 10.3109/0284186X.2014.928419. Epub 2014 Jun 24.
citation: Gronborg C, Vestergaard A, Hoyer M, Sohn M, Pedersen EM, Petersen JB, Agerbaek M, Muren LP. Intra-fractional bladder motion and margins in adaptive radiotherapy for urinary bladder cancer. Acta Oncol. 2015;54(9):1461-6. doi: 10.3109/0284186X.2015.1062138. Epub 2015 Aug 27.