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Clinical trial

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

ID
Name
HyBla_RCT
Description
Analysis of the efficacy and the compatibility of deep regional hyperthermia in combination with radiotherapy and chemoradiotherapy in bladder cancer
Trial arms
Trial start
2017-03-29
Estimated PCD
2098-12-31
Trial end
2099-12-31
Status
Recruiting
Treatment
Hyperthermia
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).
Arms:
Standard Arm
Other names:
Thermal therapy or thermotherapy
Radiotherapy
50,4 Gy (28 x 1,8 Gy) plus Boost: If R0: 5,4 Gy; If R1/2: 9 Gy
Arms:
Standard Arm
Chemotherapy 5-Fluorouracil
600 mg/m\^2 civ 120h; d 1-5, 29-33
Arms:
Standard Arm
Chemotherapy Cisplatin
20 mg/m\^2; d1-5, 29-33
Arms:
Standard Arm
Size
1000
Primary endpoint
Overall survival
Participants will be followed for up to 5 years after the end of therapy
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 1000, 'type': 'ESTIMATED'}}
Updated at
2024-05-09

1 organization

2 products

1 indication

Organization
University of Erlangen-Nürnberg Medical School
Product
5-Fluorouracil
Indication
Bladder Cancer
Product
Cisplatin