Image-Guided Tumorboost of Bladder Cancer

• Sponsor: University of Aarhus (Other)
• Overall Status: Completed
• CT.gov ID: NCT00963404
• Collaborator: Aarhus University Hospital (Other)
• Enrollment: 19
• Locations: 4
• Arm: 1
• Duration (Months): 89
• Patients Per Site: 4.8
• Patients Per Site Per Month: 0.1

Study Details

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
• Actual Enrollment: 19 participants
• Allocation: N/A
• 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: Aug 1, 2009
• Actual Primary Completion Date: Jan 1, 2017
• Actual Study Completion Date: Jan 1, 2017

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 [One year]

Secondary Outcome Measures

1. Acute and late adverse effects of the radiotherapy treatment [3 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	The department of Oncology, Aarhus University Hospital	Aarhus		Denmark	Dk-8000
2	The department of Oncology, Rigshospitalet	Copenhagen		Denmark	Dk-2100
3	The department of Oncology, Herlev University Hospital	Herlev		Denmark	Dk-2730
4	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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: University of Aarhus
• ClinicalTrials.gov Identifier: NCT00963404
• Other Study ID Numbers: CIRRO IP 070109 DaBlaCa-1; M-20080210
• First Posted: Aug 21, 2009
• Last Update Posted: May 3, 2018
• Last Verified: Jan 1, 2018

• Keywords provided by University of Aarhus: Image-guided Radiotherapy; Fiducial marker; Adverse effects
• Additional relevant MeSH terms: Urinary Bladder Neoplasms

Study Results

No Results Posted as of May 3, 2018