Adverse Effects for Adaptive RT of Bladder Cancer Clinical Trial
— plan selectionOfficial title:
Adaptive Radiotherapy Using Plan Selection for Bladder Cancer: A Phase II Trial
Verified date | December 2015 |
Source | University of Aarhus |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 65 |
Est. completion date | October 30, 2016 |
Est. primary completion date | October 30, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Oncology, Aarhus University Hospital | Aarhus | |
Denmark | Herlev Hospital | Herlev | |
Denmark | Odense University Hospital | Odense |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus | Copenhagen University Hospital at Herlev, Odense University Hospital |
Denmark,
Grønborg C, Vestergaard A, Høyer M, Söhn M, Pedersen EM, Petersen JB, Agerbæk 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. — View Citation
Vestergaard A, Hafeez S, Muren LP, Nill S, Høyer M, Hansen VN, Grønborg 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. — View Citation
Vestergaard A, Muren LP, Lindberg H, Jakobsen KL, Petersen JB, Elstrøm UV, Agerbæk M, Høyer 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: — View Citation
Vestergaard A, Søndergaard J, Petersen JB, Høyer 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Gastro- Intestinal toxicity | 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 | Up to 2 years after ART | |
Secondary | Intra-fractional changes of bladder shape and size | CineMR (time resolved MR) is performed pre-treatment and weekly during RT for the first 10 patients | spring 2013 | |
Secondary | Difference in accumulated dose to normal tissue | The gain of normal tissue sparring will be calculated using dose accumulation | autum 2014 | |
Secondary | 1 or 2 years disease free survival | 1 or 2 years disease free survival will be calculated | 2015 |