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Image-Guided Tumorboost of Bladder Cancer

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ClinicalTrials.gov Identifier: NCT00963404
Recruitment Status : Unknown
Verified November 2015 by University of Aarhus.
Recruitment status was:  Active, not recruiting
First Posted : August 21, 2009
Last Update Posted : December 7, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Bladder Neoplasms Radiation: Radiation boost Phase 1 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Image-guided Tumorboost of Localized Unifocal Bladder Cancer: A Phase I/II Study
Study Start Date : August 2009
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. Local tumor control [ Time Frame: One year ]

Secondary Outcome Measures :
  1. Acute and late adverse effects of the radiotherapy treatment [ Time Frame: 3 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: August 21, 2009    Key Record Dates
Last Update Posted: December 7, 2015
Last Verified: November 2015

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

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