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 type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 1000 (estimated) |
| Sponsor | University of Erlangen-Nürnberg Medical School Academic / other |
| Locations | 1 site (Erlangen) |
| Status | Recruiting |
| Started | March 29, 2017 |
| Main results expected | December 31, 2098 |
| Study ends | December 31, 2099 |
| Registry record updated | May 9, 2024 |
| Trial ID | NCT05397262 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
- Principal investigator: Oliver Ott, MD — Dept. of Radiation Therapy, University Hospital Erlangen
- Study coordinator: Oliver Ott, MD
- Email: oliver.ott@uk-erlangen.de
- Phone: ++49(0)913185
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.