Combining radiation and hyperthermia for advanced cervical cancer treatment
Multimodal Therapy of Advanced Cervical Cancer With Radiotherapy or Chemoradiation, Interstitial Brachytherapy in Combination With Hyperthermia
This study tests if combining radiation therapy and heat treatment can improve outcomes for people with advanced cervical cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 999 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Erlangen-Nürnberg Medical School Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Erlangen) |
| Trial ID | NCT03249519 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of combining radiation therapy or chemoradiation with interstitial brachytherapy and hyperthermia in patients with advanced cervical cancer. The aim is to enhance the treatment outcomes by leveraging the radio- and chemosensitive effects of hyperthermia. Eligible participants include those with histologically confirmed cervical carcinoma at specific stages, and the study will assess the clinical outcomes of this combined approach. The interventions include radiation, brachytherapy, Cisplatin, and hyperthermia.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed cervical cancer at FIGO stages IIB to IVA.
Not a fit: Patients with uncontrolled cardiac conditions or those who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve treatment outcomes for patients with advanced cervical cancer.
How similar studies have performed: Other studies have shown promising results with similar combinations of therapies, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histological confirmed carcinoma of the Cervix * FIGO-Stage IIB-IVA; earlier stages when inoperable or according to patient's wish * clinical M0; except: involvement of para-aortic lymph nodes * Age ≥ 18 years * ECOG ≤ 2 * Informed consent of the patient 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 chemoradiation or deep regional hyperthermia * Metal implants (length \> 2cm or dense clusters of marker clips in the pelvis) * Active or therapy-resistent bladder infections * Pre-existing or concommitant immunodeficiency Syndrome * 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
- Universitätsklinikum Erlangen, Strahlenklinik — Erlangen, Germany (Recruiting)
Study contacts
- Study coordinator: Oliver Ott, MD
- Email: st-studiensekretariat@uk-erlangen.de
- Phone: ++49 9131 85
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.