Organ-preservative Therapy of Bladder Cancer With Radiotherapy or Radiochemotherapy Combined With Hyperthermia (HyBla_RCT)

  • STATUS
    Recruiting
  • End date
    Dec 31, 2099
  • participants needed
    1000
  • sponsor
    University of Erlangen-Nürnberg Medical School
Updated on 13 June 2022
fluorouracil
bladder tumor

Summary

Analysis of the efficacy and the compatibility of deep regional hyperthermia in combination with radiotherapy and chemoradiotherapy in bladder cancer

Details
Condition Bladder Cancer
Treatment Radiotherapy, hyperthermia, Chemotherapy 5-Fluorouracil, Chemotherapy Cisplatin
Clinical Study IdentifierNCT05397262
SponsorUniversity of Erlangen-Nürnberg Medical School
Last Modified on13 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age ≥ 18 years
Histologically confirmed bladder cancer
M0
ECOG-performance status ≤ 2
Informed consent

Exclusion Criteria

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
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