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

Study Overview
=================
Brief Summary
-----------------
Analysis of the efficacy and the compatibility of deep regional hyperthermia in combination with radiotherapy and chemoradiotherapy in bladder cancer

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

Conditions
-----------------
Bladder Cancer

Intervention / Treatment
-----------------
* Other: Hyperthermia
* Radiation: Radiotherapy
* Drug: Chemotherapy 5-Fluorouracil
* Drug: Chemotherapy Cisplatin


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Standard Arm<br>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 | Other: Hyperthermia<br>* 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).<br>* Other names: Thermal therapy or thermotherapy;Radiation: Radiotherapy<br>* 50,4 Gy (28 x 1,8 Gy) plus Boost: If R0: 5,4 Gy; If R1/2: 9 Gy<br>Drug: Chemotherapy 5-Fluorouracil<br>* 600 mg/m^2 civ 120h; d 1-5, 29-33<br>Drug: Chemotherapy Cisplatin<br>* 20 mg/m^2; d1-5, 29-33<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Overall survival | Participants will be followed for up to 5 years after the end of therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Disease free survival | Length of survival without disease recurrence | Participants will be followed for up to 5 years after the end of therapy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bladder cancer, Hyperthermia, Radiotherapy, Chemotherapy