Image-Guided Tumorboost of Bladder Cancer
This study is currently recruiting participants.
Verified November 2012 by University of Aarhus
Sponsor:
University of Aarhus
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00963404
First received: August 20, 2009
Last updated: November 1, 2012
Last verified: November 2012
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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 ]
| Estimated Enrollment: | 30 |
| Study Start Date: | August 2009 |
| Estimated Study Completion Date: | January 2014 |
| Estimated Primary Completion Date: | January 2014 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00963404
Contacts
| Contact: Jimmi Sondergaard | +4589492651 | jimmsoen@rm.dk |
| Contact: Morten Hoyer | +4589492529 | morthoey@rm.dk |
Locations
| Denmark | |
| The department of Oncology, Aarhus University Hospital | Recruiting |
| Aarhus, Denmark, Dk-8000 | |
| Contact: Jimmi Sondergaard jimmsoen@rm.dk | |
| Contact: Morten Hoyer | |
| Principal Investigator: Jimmi Sondergaard | |
| The department of Oncology, Rigshospitalet | Not yet recruiting |
| Copenhagen, Denmark, Dk-2100 | |
| Contact: Peter M Petersen peter.meidahl.petersen@rh.regionh.dk | |
| Principal Investigator: Peter M Petersen | |
| The department of Oncology, Herlev University Hospital | Recruiting |
| Herlev, Denmark, Dk-2730 | |
| Contact: Lisa Sengelov LISE@heh.regionh.dk | |
| Principal Investigator: Lisa Sengelov | |
| The department of Oncology, Odense University Hospital | Not yet recruiting |
| Odense, Denmark, Dk-5000 | |
| Contact: Niels V Jensen Niels.Viggo.Jensen@ouh.regionsyddanmark.dk | |
| Contact: Steinbjørn Hansen | |
| Principal Investigator: Niels V Jensen | |
| Sub-Investigator: Steinbjørn Hansen | |
| Sub-Investigator: Lars Dysager | |
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:
No publications provided
| 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: | November 1, 2012 |
| 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 Urologic Neoplasms Urogenital Neoplasms |
Neoplasms by Site Urinary Bladder Diseases Urologic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013