NCT03249519 Radiation Therapy or Chemoradiation, Interstitial Brachytherapy in Combination With Hyperthermia in Advanced Cervical Cancer
| NCT ID | NCT03249519 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Erlangen-Nürnberg Medical School |
| Condition | Cervical Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 999 participants |
| Start Date | 2017-08-01 |
| Primary Completion | 2094-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 999 participants in total. It began in 2017-08-01 with a primary completion date of 2094-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The combination of radiation therapy or chemoradiation with Interstitial brachytherapy for advanced cervical cancer (pN+, FIGO-Stage II B - IV A is standard of therapy. The radio- and chemosensitive effect of an additional hyperthermia might improve the clinical outcome.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT03249519 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Cervical Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03249519 currently recruiting?
Yes, NCT03249519 is actively recruiting participants. Contact the research team at st-studiensekretariat@uk-erlangen.de for enrollment information.
Where is the NCT03249519 trial being conducted?
This trial is being conducted at Erlangen, Germany.
Who is sponsoring the NCT03249519 clinical trial?
NCT03249519 is sponsored by University of Erlangen-Nürnberg Medical School. The trial plans to enroll 999 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.