Image-Guided Tumorboost of Bladder Cancer

This study is currently recruiting participants.
Verified November 2012 by University of Aarhus
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00963404
First received: August 20, 2009
Last updated: November 1, 2012
Last verified: November 2012
  Purpose

The purpose of the study is to increase the radiation dose (Boost) to the bladder tumor. The bladder cancer patients included in the study will undergo tumor demarcation. The bladder demarcations will then be the target for an image-guided boost delivered precisely to the expected tumor site.


Condition Intervention Phase
Bladder Neoplasms
Radiation: Radiation boost
Phase 1
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: Image-guided Tumorboost of Localized Unifocal Bladder Cancer: A Phase I/II Study

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Local tumor control [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Acute and late adverse effects of the radiotherapy treatment [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: August 2009
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tumor-boost
Image-guided tumorboost of the bladder cancer.
Radiation: Radiation boost
Radiation boost of the bladder-tumor: 10 Gy/5 fractions, 2 Gy per fraction.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Muscle invasive bladder cancer (transitional carcinoma)
  • Unifocal
  • TNM stage T2a-4a, N0-1, M0
  • unfit for radical cystectomy

Exclusion Criteria:

  • Hyperthyroidism
  • Multinodular goiter
  • Pregnancy
  • Breast feeding
  • WHO preformance status more than 2
  • Iodine allergy
  • MRI or CT contrast media allergy
  • Bi-lateral hip-prosthesis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00963404

Contacts
Contact: Jimmi Sondergaard +4589492651 jimmsoen@rm.dk
Contact: Morten Hoyer +4589492529 morthoey@rm.dk

Locations
Denmark
The department of Oncology, Aarhus University Hospital Recruiting
Aarhus, Denmark, Dk-8000
Contact: Jimmi Sondergaard       jimmsoen@rm.dk   
Contact: Morten Hoyer         
Principal Investigator: Jimmi Sondergaard         
The department of Oncology, Rigshospitalet Not yet recruiting
Copenhagen, Denmark, Dk-2100
Contact: Peter M Petersen       peter.meidahl.petersen@rh.regionh.dk   
Principal Investigator: Peter M Petersen         
The department of Oncology, Herlev University Hospital Recruiting
Herlev, Denmark, Dk-2730
Contact: Lisa Sengelov       LISE@heh.regionh.dk   
Principal Investigator: Lisa Sengelov         
The department of Oncology, Odense University Hospital Not yet recruiting
Odense, Denmark, Dk-5000
Contact: Niels V Jensen       Niels.Viggo.Jensen@ouh.regionsyddanmark.dk   
Contact: Steinbjørn Hansen         
Principal Investigator: Niels V Jensen         
Sub-Investigator: Steinbjørn Hansen         
Sub-Investigator: Lars Dysager         
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital
Investigators
Principal Investigator: Jimmi Sondergaard The department of Oncology, Aarhus University Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT00963404     History of Changes
Other Study ID Numbers: CIRRO IP 070109 DaBlaCa-1, M-20080210
Study First Received: August 20, 2009
Last Updated: November 1, 2012
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
Image-guided Radiotherapy
Fiducial marker
Adverse effects

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

ClinicalTrials.gov processed this record on April 22, 2014