RecruitingNot ApplicableNCT03249519
Radiation Therapy or Chemoradiation, Interstitial Brachytherapy in Combination With Hyperthermia in Advanced Cervical Cancer
Multimodal Therapy of Advanced Cervical Cancer With Radiotherapy or Chemoradiation, Interstitial Brachytherapy in Combination With Hyperthermia
Sponsor
University of Erlangen-Nürnberg Medical School
Enrollment
999 participants
Start Date
Aug 1, 2017
Study Type
INTERVENTIONAL
Conditions
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
Sex: FEMALEMin Age: 18 Years
Inclusion Criteria6
- 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 Criteria12
- 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
Interventions
RADIATIONRadiation
50.4 Gy
RADIATIONbrachytherapy
35-40 Gy
DRUGCisplatin
weekly 40 mg/m\^2 (6cycles)
OTHERHyperthermia
10 times
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT03249519
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