Treatment for bladder cancer using heat and radiation therapy
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
This study tests if using heat along with radiation and chemotherapy can help people with bladder cancer have better treatment results.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Erlangen-Nürnberg Medical School Academic / other |
| Locations | 1 site (Erlangen) |
| Trial ID | NCT05397262 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed bladder cancer and a performance status of 2 or lower.
Not a fit: Patients with uncontrolled cardiac conditions, significant heart disease, or those with active bladder infections may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Erlangen
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.