Intensive intraperitoneal therapy in advanced ovarian cancer combining cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC) and postoperative intraperitoneal chemotherapy (IPC). - INTENS-IP

Institut Régional du Cancer de Montpellier (ICM)0 个研究点目标入组 55 人开始时间: 2019年10月21日最近更新: 2024年3月26日

适应症

试验速览

暂无简介。

•-Patients aged 18 to 75 years,
•-Patients with high-grade serous (high grade according to MD Anderson, grade II and III according to Silverman) ovarian or tubal or primitive peritoneal histologically proven cancer,
•-Initial laparoscopy confirming the histological type, evaluating the extent of the disease by PCI score and confirming the initial non-resectability,
•-Stage III B-C (FIGO 2014) or stage IVA with minimal or moderate pleural effusion,
•-Complete interval cytoreduction surgery,
•-Indication of 3 to 4 cures of neoadjuvant chemotherapy based on the Carboplatin-Paclitaxel (carbo-taxol) combination,
•-The delay between the last course of NAT and the surgery must be between 4 and 8 weeks,
•-Hematologic function, hemoglobin = 10 g / dl; PNN = 1 x 109 / L, platelets = 100 x 109 / L,
•-Total bilirubin = 1.5 LSN, ALT or AST = 3 ULN,
•-Absence of renal insufficiency (creatinine clearance = 70 ml / min) according to the MDRD method,
•-Informed consent signed before any specific procedure under consideration,
•-Patients affiliated to the French social security scheme or equivalent.
•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 55
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 55

•-Performance Index (WHO) = 2,
•-Stage IV B or IV A with significant pleural effusion,
•-Renal impairment (clearance <70 ml / min) according to the MDRD method,
•-General contraindication to the realization of a tumor reduction surgery or HIPEC (contraindication or history allergic reaction to any treatments components),
•-Hepatic insufficiency (bilirubin > 1.5 x normal, ASAT & ALAT > 3 x upper limit of normal),
•-Serious life-threatening co-existing condition at stake,
•-Cardio-respiratory pathology indicating hyper hydration, to be implemented for HIPEC,
•-Patient who has already been treated with chemo-hyperthermia for ovarian cancer,
•-History of cancer, except basal cell carcinoma of the skin or carcinoma in situ of cervix having recurred within five years prior to entry into this trial,
•-Any severe untreated infectious disease,
•-Peripheral sensory neuropathy = grade 2 at the inclusion time,
•-Patients whose regular follow-up is a priori impossible for psychological, family, social or geographical reasons,
•-Pregnant and / or nursing women,
•-Subjects under tutelage, curatorship or safeguard of justice.

发起方

Institut Régional du Cancer de Montpellier (ICM)