Clinical trial · Interventional
Organ-preservative Therapy of Bladder Cancer With Radiotherapy or Radiochemotherapy Combined With Hyperthermia
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
NCT05397262CI-TRIAL-00076989HyBla_RCTrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Analysis of the efficacy and the compatibility of deep regional hyperthermia in combination with radiotherapy and chemoradiotherapy in bladder cancer
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy 5-Fluorouracil | Drug | — | UNRESOLVED |
| Chemotherapy Cisplatin | Drug | — | UNRESOLVED |
| Hyperthermia | Other | — | UNRESOLVED |
| Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Standard Arm
- 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
- interventionNames
- Other: Hyperthermia
- Radiation: Radiotherapy
- Drug: Chemotherapy 5-Fluorouracil
- Drug: Chemotherapy Cisplatin
Primary outcomes (1)
- measure
- Overall survival
- timeFrame
- Participants will be followed for up to 5 years after the end of therapy
- description
- Overall survival
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.