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

Not Applicable

Recruiting

• Conditions: Bladder Cancer
• Interventions: Other: Hyperthermia; Radiation: Radiotherapy; Drug: Chemotherapy 5-Fluorouracil; Drug: Chemotherapy Cisplatin

• Registration Number: NCT05397262
• Lead Sponsor: University of Erlangen-Nürnberg Medical School

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-29
• Study First Submitted: 2017-04-10
• Study First Submitted QC: 2022-05-25
• Study First Posted: 2022-05-31
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-08
• Last Update Posted: 2024-05-09
• Primary Completion: 2098-12-31
• Study Completion: 2099-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Standard Arm	Hyperthermia	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
Standard Arm	Radiotherapy	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
Standard Arm	Chemotherapy 5-Fluorouracil	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
Standard Arm	Chemotherapy Cisplatin	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

Primary Outcome Measures

Name	Time	Method
Overall survival	Participants will be followed for up to 5 years after the end of therapy	Overall survival

Secondary Outcome Measures

Name	Time	Method
Disease free survival	Participants will be followed for up to 5 years after the end of therapy	Length of survival without disease recurrence
Bladder preservation rate	Participants will be followed for up to 5 years after the end of therapy	Rate of patients where bladder can be preserved

Trial Locations

Locations (1)

Dept. of Radiation Therapy, University Hospital Erlangen; 🇩🇪 Erlangen, Germany