Radiation Therapy or Chemoradiation, Interstitial Brachytherapy in Combination With Hyperthermia in Advanced Cervical Cancer
Rekrutierend
NCT-Nummer:
NCT03249519
Studienbeginn:
August 2017
Letztes Update:
15.08.2017
Wirkstoff:
Cisplatin
Indikation (Clinical Trials):
Uterine Cervical Neoplasms, Hyperthermia, Fever
Geschlecht:
Frauen
Altersgruppe:
Erwachsene (18+)
Phase:
-
Sponsor:
University of Erlangen-Nürnberg Medical School
Collaborator:
-
Kontakt
Oliver Ott, MD
Kontakt:
Phone: ++49 9131 85
Phone (ext.): 33968
E-Mail: st-studiensekretariat@uk-erlangen.de» Kontaktdaten anzeigen
Rainer Fietkau, MD
Kontakt:
Phone: ++49 9131 85
Phone (ext.): 33968
E-Mail: st-studiensekretariat@uk-erlangen.de» Kontaktdaten anzeigen
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.
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
Primary outcome:
1. Overall survival (Time Frame - 5 years)
Secondary outcome:
1. Disease free survival (local / distant / overall) (Time Frame - 5 years)
2. Safety by Toxicity assessment according to NCI CTCAE v4.0 (Time Frame - 5 years)
- Radiation (Radiation therapy):
50.4 Gy - brachytherapy (Interstitial brachytherapy):
35-40 Gy - Cisplatin:
weekly 40 mg/m^2 (6cycles) - Hyperthermia:
10 times
Quelle: ClinicalTrials.gov
Sie können folgenden Inhalt einem Kollegen empfehlen:
"Radiation Therapy or Chemoradiation, Interstitial Brachytherapy in Combination With Hyperthermia in Advanced Cervical Cancer"
Bitte tragen Sie auch die Absenderdaten vollständig ein, damit Sie der Empfänger erkennen kann.
Die mit (*) gekennzeichneten Angaben müssen eingetragen werden!
