An International Multi Center Phase III Study of Chemoradiotherapy Versus Chemoradiotherapy Plus Hyperthermia for Locally Advanced Cervical Cancer

Fecha de inicio: 1 de marzo de 2003

Inclusion criteria: Invasive cervical carcinoma (squamous, adeno or adenosquamous histologies, small cell histology excluded) * age \>18years * International Federation of Gynecology and Obstetrics ((FIGO) stage IB2, IIA-IVA, FIGO stages IA, IB1 with positive pelvic lymph nodes or parametria either on imaging techniques or pathologically involved at the time of surgery. patients undergoing surgical removal of the cervix and uterus are not eligible, parametria either on imaging techniques or pathologically involved at the time • Performance status Eastern Cooperative Oncology Group(ECOG)/World Health Organisation (WHO) 0, 1 or \>/=70%respectively White Blood count (WBC) ≥ 3,000, platelets ≥ 100,000, Absolute Neutrophil Count (ANC) \> 1500 • serum bilirubin ≤ 1.5 times upper limit of normal, transaminase ≤ 3 times upper limit of normal calculated creatinine clearance \>60milliliters (mls)/liter ( Cockcroft) OR creatinine \</= 2.0mgs% paraaortic adenopathy absent or 1.5 centimeter (cm) in greatest dimension on Computerised Tomography (CT) or Magnetic Resonance Imaging (MRI) scan; No history of myocardial infarction in the last 6 months no symptomatic angina pectoris negative pregnancy test in patients under 50 Hemoglobin \>12.0 Gd/dl or \>7.5 mmo;/L with transfusion if needed written written informed consent Exclusion criteria: surgical resection of the primary tumor (i.e. Total abdominal hysterectomy (TAH)/ Bilateral salpingoophorectomy (BSO) * patients with pacemakers or implanted defibrillators * patients with significant metallic foreign bodies (i.e. hip replacements, bone metallic rods,orthopedic plates, etc.) * prior radiotherapy or chemotherapy