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

University of Erlangen-Nürnberg Medical School

Status: Enrolling

Conditions: Bladder Cancer

Treatments: Other: Hyperthermia; Radiation: Radiotherapy; Drug: Chemotherapy Cisplatin; Drug: Chemotherapy 5-Fluorouracil

Study type: Interventional

Funder types: Other

Identifiers

NCT05397262

HyBla_RCT

Details and patient eligibility

About

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

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,000 participants in 1 patient group

Standard Arm

Other group

Description:

1 Arm: combination Treatment: Deep regional hyperthermia: 1-2/week up to 10 sessions Radiotherapy: 50.4Gy + Boost 5.4Gy (R0) or 9.0Gy (R1/2) Chemotherapy: 5-Fluorouracil 600mg/m\^2, civ 120h; d1-5, 29-3 Chemotherapy: Cisplatin 20mg/m\^2; d1-5, 29-33

Treatment:

Radiation: Radiotherapy

Drug: Chemotherapy Cisplatin

Drug: Chemotherapy 5-Fluorouracil

Other: Hyperthermia