Adaptive Radiotherapy Using Plan Selection for Bladder Cancer (plan selection)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University of Aarhus
Sponsor:
Collaborator:
Herlev Hospital, Denmark
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01762527
First received: January 3, 2013
Last updated: January 7, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Adverse Effects for Adaptive RT of Bladder Cancer
Radiation: Adaptive Radiotherapy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Adaptive Radiotherapy Using Plan Selection for Bladder Cancer: A Phase II Trial

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Gastro- Intestinal toxicity [ Time Frame: Up to 2 years after ART ] [ Designated as safety issue: Yes ]
    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:
  • Intra-fractional changes of bladder shape and size [ Time Frame: spring 2013 ] [ Designated as safety issue: Yes ]
    CineMR (time resolved MR) is performed pre-treatment and weekly during RT for the first 10 patients

  • Difference in accumulated dose to normal tissue [ Time Frame: autum 2014 ] [ Designated as safety issue: Yes ]
    The gain of normal tissue sparring will be calculated using dose accumulation

  • 1 or 2 years disease free survival [ Time Frame: 2015 ] [ Designated as safety issue: Yes ]
    1 or 2 years disease free survival will be calculated


Estimated Enrollment: 65
Study Start Date: October 2012
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ART
Online adaptive radiotherapy
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
Other Name: Online Adaptive RT using plan selection

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01762527

Contacts
Contact: Morten Høyer, MD, PhD, Prof. +45 7846 2529 hoyer@aarhus.rm.dk

Locations
Denmark
Department of Oncology, Aarhus University Hospital Recruiting
Aarhus, Denmark, 8000 C
Contact: Morten Høyer, MD, PhD, Prof.    +45 7846 2529    hoyer@aarhus.rm.dk   
Contact: Anne Vestergaard, MSc.    +45 7846 2572    annveste@rm.dk   
Principal Investigator: Morten Høyer, MD, PhD, Prof.         
Herlev Hospital Not yet recruiting
Herlev, Denmark, 2730
Contact: Henriette Lindberg, MD, PhD    +4538689597    Henriette.Lindberg@regionh.dk   
Principal Investigator: Henriette Lindberg, MD, PhD         
Sponsors and Collaborators
University of Aarhus
Herlev Hospital, Denmark
Investigators
Principal Investigator: Morten Høyer, MD, Professor Aarhus University Hospital
  More Information

Additional Information:
Publications:
Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01762527     History of Changes
Other Study ID Numbers: AUH-KFE-1217, jr.nr. 1-16-02-283-12
Study First Received: January 3, 2013
Last Updated: January 7, 2013
Health Authority: Denmark: Ethics Committee
Denmark: Danish Dataprotection Agency

Keywords provided by University of Aarhus:
Adaptive radiotherapy
Bladder cancer

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on September 16, 2014