Adaptive Radiotherapy Using Plan Selection for Bladder Cancer

Not Applicable

Completed

• Conditions: Adverse Effects for Adaptive RT of Bladder Cancer
• Interventions: Radiation: Adaptive Radiotherapy

• Registration Number: NCT01762527
• Lead Sponsor: University of Aarhus

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2013-01-03
• Study First Submitted QC: 2013-01-04
• Study First Posted: 2013-01-07
• Status Verified: 2015-12
• Primary Completion: 2016-10-30
• Study Completion: 2016-10-30
• Last Update Submitted: 2021-05-04
• Last Update Posted: 2021-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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

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Exclusion Criteria

• Suspected or confirmed distant metastases
• Previous surgery in the small pelvis
• Inflammatory bowel disease

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ART	Adaptive Radiotherapy	Online adaptive radiotherapy

Primary Outcome Measures

Name	Time	Method
Gastro- Intestinal toxicity	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

Secondary Outcome Measures

Name	Time	Method
Intra-fractional changes of bladder shape and size	spring 2013	CineMR (time resolved MR) is performed pre-treatment and weekly during RT for the first 10 patients
Difference in accumulated dose to normal tissue	autum 2014	The gain of normal tissue sparring will be calculated using dose accumulation
1 or 2 years disease free survival	2015	1 or 2 years disease free survival will be calculated

Trial Locations

Locations (3)

Department of Oncology, Aarhus University Hospital; 🇩🇰 Aarhus, Denmark

Herlev Hospital; 🇩🇰 Herlev, Denmark

Odense University Hospital; 🇩🇰 Odense, Denmark