Adaptive Radiotherapy Using Plan Selection for Bladder Cancer

Adverse Effects for Adaptive RT of Bladder Cancer Clinical Trial

— plan selection  

Official title:

Adaptive Radiotherapy Using Plan Selection for Bladder Cancer: A Phase II Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01762527
• Other study ID #: AUH-KFE-1217
• Secondary ID: jr.nr. 1-16-02-2
• Status: Completed
• Phase: N/A
• Start date: October 2012
• Est. completion date: October 30, 2016

Study information

• Verified date: December 2015
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Adverse Effects for Adaptive RT of Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

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

Locations

Country	Name	City	State
Denmark	Department of Oncology, Aarhus University Hospital	Aarhus
Denmark	Herlev Hospital	Herlev
Denmark	Odense University Hospital	Odense

Sponsors (3)

Lead Sponsor	Collaborator
University of Aarhus	Copenhagen University Hospital at Herlev, Odense University Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (4)

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

Outcome

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

External Links

•   Protocol in Danish