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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05397262

Acronym

HyBla_RCT

Enrollment

1000

Registered

2022-05-31

Start date

2017-03-29

Completion date

2099-12-31

Last updated

2024-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer

Keywords

bladder cancer, Hyperthermia, Radiotherapy, Chemotherapy

Brief summary

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

Interventions

OTHERHyperthermia

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).

RADIATIONRadiotherapy

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

DRUGChemotherapy 5-Fluorouracil

600 mg/m\^2 civ 120h; d 1-5, 29-33

DRUGChemotherapy Cisplatin

20 mg/m\^2; d1-5, 29-33

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Overall survival	Participants will be followed for up to 5 years after the end of therapy	Overall survival

Secondary

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

Countries

Germany

Contacts

Primary ContactOliver Ott, MD

oliver.ott@uk-erlangen.de++49(0)913185

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026