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

Bladder Cancer Clinical Trial

— HyBla_RCT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05397262
• Other study ID #: HyBla_RCT
• Status: Recruiting
• Phase: N/A
• Start date: March 29, 2017
• Est. completion date: December 31, 2099

Study information

• Verified date: May 2024
• Source: University of Erlangen-Nürnberg Medical School
• Contact: Oliver Ott, MD
• Phone: ++49(0)913185
• Email: oliver.ott[@]uk-erlangen.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2099
• Est. primary completion date: December 31, 2098
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer
• Fever
• Hyperthermia
• Urinary Bladder Neoplasms

Intervention

Other:
• 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).

Radiation:
• Radiotherapy
50,4 Gy (28 x 1,8 Gy) plus Boost: If R0: 5,4 Gy; If R1/2: 9 Gy

Drug:
• Chemotherapy 5-Fluorouracil
600 mg/m^2 civ 120h; d 1-5, 29-33
• Chemotherapy Cisplatin
20 mg/m^2; d1-5, 29-33

Locations

Country	Name	City	State
Germany	Dept. of Radiation Therapy, University Hospital Erlangen	Erlangen

Sponsors (1)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	Overall survival	Participants will be followed for up to 5 years after the end of therapy
Secondary	Bladder preservation rate	Rate of patients where bladder can be preserved	Participants will be followed for up to 5 years after the end of therapy
Secondary	Disease free survival	Length of survival without disease recurrence	Participants will be followed for up to 5 years after the end of therapy