Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Treatment for bladder cancer using heat and radiation therapy

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

Run by University of Erlangen-Nürnberg Medical School · NCT05397262 · Data updated 2026-11-12

This study tests if using heat along with radiation and chemotherapy can help people with bladder cancer have better treatment results.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment1000 (estimated)
SponsorUniversity of Erlangen-Nürnberg Medical School
Academic / other
Locations1 site (Erlangen)
StatusRecruiting
StartedMarch 29, 2017
Main results expectedDecember 31, 2098
Study endsDecember 31, 2099
Registry record updatedMay 9, 2024
Trial IDNCT05397262 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 and older with histologically confirmed bladder cancer and a performance status of 2 or lower.

Probably not a fit

Patients with uncontrolled cardiac conditions, significant heart disease, or those with active bladder infections may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness and safety of combining deep regional hyperthermia with radiotherapy and chemoradiotherapy in patients with bladder cancer. The approach aims to enhance the therapeutic effects of radiation by increasing tumor temperature, potentially improving treatment outcomes. Eligible participants will receive a regimen that includes chemotherapy agents such as 5-Fluorouracil and Cisplatin alongside the heat treatment. The study focuses on patients with histologically confirmed bladder cancer who meet specific health criteria.

Why it matters

Potential benefit: If successful, this treatment could improve the effectiveness of bladder cancer therapies and preserve bladder function.

How similar studies have gone: While the combination of hyperthermia with radiotherapy is being explored, this specific approach in bladder cancer is relatively novel and has not been extensively tested in prior studies.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Dept. of Radiation Therapy, University Hospital Erlangen
    Erlangen, Germany
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.