WEEKLY vs EVERY 3 WEEK CARBOPLATIN + PACLITAXEL IN PATIENTS WITH OVARIAN CANCER: RANDOMIZED MULTICENTER STUDY - MITO-7

ISTITUTO NAZIONALE PER LO STUDIO E LA CURA DEI TUMORI - FONDAZIONE G. PASCALE0 个研究点开始时间: 2009年3月13日最近更新: 2012年3月19日

试验速览

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•· Cytologic or histologic diagnosis of ovarian carcinoma of the ovary, fallopian tube or primary peritoneal carcinoma, stage IC-IV ·Indication for chemotherapy ·Age > 18 years ·Life expectancy of at least 3 months
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•· Previous or concomitant malignant malignancy (excluding adequately treated baso-or squamocellular carcinoma of the skin and carcinoma in situ of the cervice, and synchronousl carcinoma endometrioid Stage Ib or less for the uterus, with ovarian tumor Stage II or higher) · Performance Status (ECOG) ³ 3. · Previous chemotherapy · Heart disease (congestive heart failure, myocardial infarction within 6 months from study entry, atrioventricular block of any grade, severe arrhythmias) · Neutrophils < 2000 x mm3, platelets < 100000 x mm3 · Inadequate renal function (creatinine ³ 1.25 x normal values) or liver function (ALT or AST ³ 1.25 x normal values) · Present or suspected hemorrhagic syndromes · Inability to comply with protocol and follow-up · Inability to access study site for clinical visits · Refusal of informed consent

发起方

ISTITUTO NAZIONALE PER LO STUDIO E LA CURA DEI TUMORI - FONDAZIONE G. PASCALE