Organ-preservative Therapy of Bladder Cancer With Radiotherapy or Radiochemotherapy Combined With Hyperthermia
Register-Trial Based on an Agreement of Health Insurances With the Department of Radiation Therapy of the University Hospital Erlangen for the Application of Regional Hyperthermia in Bladder Cancer: Organ-preservative Therapy of Bladder Cancer With Radiotherapy or Radiochemotherapy Combined With Hyperthermia
University of Erlangen-Nürnberg Medical School
1,000 participants
Mar 29, 2017
INTERVENTIONAL
Conditions
Summary
Analysis of the efficacy and the compatibility of deep regional hyperthermia in combination with radiotherapy and chemoradiotherapy in bladder cancer
Eligibility
Inclusion Criteria5
- Age ≥ 18 years
- Histologically confirmed bladder cancer
- M0
- ECOG-performance status ≤ 2
- Informed consent
Exclusion Criteria12
- 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
Interventions
Deep Regional Hyperthermia (RHT) 1-2/week up to 10 sessions a type of cancer treatment in which body tissue is exposed to high temperatures (up to 113°F).
50,4 Gy (28 x 1,8 Gy) plus Boost: If R0: 5,4 Gy; If R1/2: 9 Gy
600 mg/m\^2 civ 120h; d 1-5, 29-33
20 mg/m\^2; d1-5, 29-33
Locations(1)
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NCT05397262