Radiation Therapy or Chemoradiation, Interstitial Brachytherapy in Combination With Hyperthermia in Advanced Cervical Cancer

University of Erlangen-Nürnberg Medical School

Status

Enrolling

Conditions

Cervical Cancer

Treatments

Other: Hyperthermia

Radiation: Radiation

Drug: Cisplatin

Radiation: brachytherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT03249519

HyZer_RCT_IBT

Details and patient eligibility

About

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.

Enrollment

999 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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