Status:
RECRUITING
Organ-preservative Therapy of Bladder Cancer With Radiotherapy or Radiochemotherapy Combined With Hyperthermia
Lead Sponsor:
University of Erlangen-Nürnberg Medical School
Conditions:
Bladder Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Analysis of the efficacy and the compatibility of deep regional hyperthermia in combination with radiotherapy and chemoradiotherapy in bladder cancer
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Histologically confirmed bladder cancer
- M0
- ECOG-performance status ≤ 2
- Informed consent
Exclusion
- Pre-existing uncontrolled cardiac disease, signs of cardiac failure, or rhythm disturbances requiring therapy
- Cardiac Pacemaker
- Myocardial infarction within the past 12 months
- Congestive heart failure
- Complete bundle branch block
- New York Heart Association (NYHA) class III or IV heart disease
- Disease that would preclude TUR, chemoradiation or deep regional hyperthermia
- Metal implants (lenght \> 2cm or dense clusters of marker clips in the pelvis)
- Active or therapy-resistent bladder infections
- Pre-existing or concommitant immunodeficiency Syndrom
- Pregnant or lactating women
- Patients not willing to use effective contraception during and up to 6 months after therapy
Key Trial Info
Start Date :
March 29 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2099
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT05397262
Start Date
March 29 2017
End Date
December 31 2099
Last Update
May 9 2024
Active Locations (1)
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1
Dept. of Radiation Therapy, University Hospital Erlangen
Erlangen, Germany, 91054