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Image-Guided Tumorboost of Bladder Cancer

Primary Purpose

Bladder Neoplasms

Status
Completed
Phase
Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
Radiation boost
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Neoplasms focused on measuring Image-guided Radiotherapy, Fiducial marker, Adverse effects

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The department of Oncology, Aarhus University Hospital
  • The department of Oncology, Rigshospitalet
  • The department of Oncology, Herlev University Hospital
  • The department of Oncology, Odense University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tumor-boost

Arm Description

Image-guided tumorboost of the bladder cancer.

Outcomes

Primary Outcome Measures

Local tumor control

Secondary Outcome Measures

Acute and late adverse effects of the radiotherapy treatment

Full Information

First Posted
August 20, 2009
Last Updated
May 2, 2018
Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00963404
Brief Title
Image-Guided Tumorboost of Bladder Cancer
Official Title
Image-guided Tumorboost of Localized Unifocal Bladder Cancer: A Phase I/II Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Neoplasms
Keywords
Image-guided Radiotherapy, Fiducial marker, Adverse effects

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tumor-boost
Arm Type
Experimental
Arm Description
Image-guided tumorboost of the bladder cancer.
Intervention Type
Radiation
Intervention Name(s)
Radiation boost
Intervention Description
Radiation boost of the bladder-tumor: 10 Gy/5 fractions, 2 Gy per fraction.
Primary Outcome Measure Information:
Title
Local tumor control
Time Frame
One year
Secondary Outcome Measure Information:
Title
Acute and late adverse effects of the radiotherapy treatment
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jimmi Sondergaard
Organizational Affiliation
The department of Oncology, Aarhus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The department of Oncology, Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
Dk-8000
Country
Denmark
Facility Name
The department of Oncology, Rigshospitalet
City
Copenhagen
ZIP/Postal Code
Dk-2100
Country
Denmark
Facility Name
The department of Oncology, Herlev University Hospital
City
Herlev
ZIP/Postal Code
Dk-2730
Country
Denmark
Facility Name
The department of Oncology, Odense University Hospital
City
Odense
ZIP/Postal Code
Dk-5000
Country
Denmark

12. IPD Sharing Statement

Links:
URL
http://www.cirro.dk
Description
Related Info

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Image-Guided Tumorboost of Bladder Cancer

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