Image-Guided Tumorboost of Bladder Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00963404
First received: August 20, 2009
Last updated: December 4, 2015
Last verified: November 2015
  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 ]

Enrollment: 19
Study Start Date: August 2009
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (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
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: NCT00963404

Locations
Denmark
The department of Oncology, Aarhus University Hospital
Aarhus, Denmark, Dk-8000
The department of Oncology, Rigshospitalet
Copenhagen, Denmark, Dk-2100
The department of Oncology, Herlev University Hospital
Herlev, Denmark, Dk-2730
The department of Oncology, Odense University Hospital
Odense, Denmark, Dk-5000
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:
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: December 4, 2015
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
Neoplasms by Site
Urinary Bladder Diseases
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms

ClinicalTrials.gov processed this record on May 26, 2016