Bladder Neoplasms Clinical Trial
Official title:
Image-guided Tumorboost of Localized Unifocal Bladder Cancer: A Phase I/II Study
Verified date | January 2018 |
Source | University of Aarhus |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus | Aarhus University Hospital |
Denmark,
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 |
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