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NCT00963404 Clinical Trial

Image-Guided Tumorboost of Bladder Cancer

Bladder Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00963404
Other study ID # CIRRO IP 070109 DaBlaCa-1
Secondary ID M-20080210
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date August 2009
Est. completion date January 2017

Study information
Verified date January 2018
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 19
Est. completion date January 2017
Est. primary completion date January 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Radiation:
• Radiation boost
Radiation boost of the bladder-tumor: 10 Gy/5 fractions, 2 Gy per fraction.

Locations
Country Name City State
Denmark The department of Oncology, Aarhus University Hospital Aarhus
Denmark The department of Oncology, Rigshospitalet Copenhagen
Denmark The department of Oncology, Herlev University Hospital Herlev
Denmark The department of Oncology, Odense University Hospital Odense

Sponsors (2)
Lead Sponsor Collaborator
University of Aarhus Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Local tumor control One year
Secondary Acute and late adverse effects of the radiotherapy treatment 3 years
See also
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Terminated NCT00191477 - Instillation of Gemcitabine in Patients With Superficial Bladder Cancer Phase 3
Recruiting NCT05072600 - Pembrolizumab Monotherapy Following Tri-modality Treatment for Selected Patients With Muscle-invasive Bladder Cancer Phase 2
Active, not recruiting NCT00109655 - Dose-Escalation Study of CG0070 for Bladder Cancer After BCG (Bacillus Calmette-Guerin) Failure Phase 1
Completed NCT00188695 - Combidex USPIO - Ultra-small Superparamagnetic Iron Oxide Phase 1/Phase 2
Active, not recruiting NCT00871754 - Molecular Analysis Of Bladder Cancer

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