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Image-guided Tumorboost of Localized Unifocal Bladder Cancer: A Phase I/II Study


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Bladder Neoplasms

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Trial Information

Image-guided Tumorboost of Localized Unifocal Bladder Cancer: A Phase I/II Study


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Local tumor control

Outcome Time Frame:

One year

Safety Issue:

No

Principal Investigator

Jimmi Sondergaard

Investigator Role:

Principal Investigator

Investigator Affiliation:

The department of Oncology, Aarhus University Hospital

Authority:

Denmark: Danish Dataprotection Agency

Study ID:

CIRRO IP 070109 DaBlaCa-1

NCT ID:

NCT00963404

Start Date:

August 2009

Completion Date:

January 2014

Related Keywords:

  • Bladder Neoplasms
  • Image-guided Radiotherapy
  • Fiducial marker
  • Adverse effects
  • Urinary Bladder Neoplasms
  • Neoplasms

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