Assessment of cytoreductive surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in first or secondary platinum-resistant recurrent ovarian epithelial cancer.HIPOVA-01 - HIPOVA-01

Hospices Civils de Lyon0 个研究点目标入组 220 人开始时间: 2019年6月17日最近更新: 2021年7月26日

适应症

试验速览

暂无简介。

•-18 < age = 75 years;
•-First or second recurrence of platin-resistant epithelial ovarian cancer (clinical recurrence or persistence within 6 months of last treatment);
•-White Blood cell Count >3,500/mm3, neutrophils =1,500/mm3, platelets =100,000/mm3;
•-Good renal function: CKD-EPI >60 ml/min/1.73 m²;
•-Eastern Cooperative Oncology Group Performance Status (ECOG PS) =2;
•-Serum bilirubin =1.5 x Upper Limit of Normal (ULN);
•-Prior debulking surgery whatever the residue
•-Information on the residue of the debulking surgery available (R0 or R+)
•-Treated with a maximum of two previous lines of chemotherapy
•-Covered by a Healthcare System;
•-Signed written informed consent obtained prior to any study-specific screening procedures.
•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 180
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 40

•-Platinum-refractory EOC (i.e. progression under platinum containing chemotherapy);
•-History of breast cancer or previous malignancies not considered in complete remission for at least 2 years;
•-Pregnant or lactating females. Serum pregnancy test to be assessed within 7 days prior to study treatment start, or within 14 days (with a confirmatory urine pregnancy test within 7 days prior to study treatment start);
•-Women of childbearing potential (defined as <2 years after last menstruation and not surgically sterile) not using highly-effective, hormonal or non-hormonal means of contraception (i.e. intrauterine contraceptive device) during the study and for 6 months after the last dose of study medication;
•-Untreated central nervous system disease or symptomatic central nervous system metastasis;
•-History or evidence of thrombotic or haemorrhagic disorders within 6 months before first study treatment;
•-Uncontrolled hypertension (sustained systolic = 140 mmHg and/or diastolic = 90 mmHg confirmed by 2 measures despite antihypertensive therapy) or clinically significant (i.e. active) cardiovascular disease;

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