EFFICACY AND SAFETY OF EARLY POSTOPERATIVE CHEMOTHERAPY INTRAPERITONEAL (EPIC) WITH PACLITAXEL IN THE RADICAL SURGERY TREATMENT OF OVARIAN PERITONEAL CARCINOMATOSIS

FUNDACIÓN PARA LA INVESTIGACIÓN BIOMÉDICA DE CÓRDOBA0 个研究点目标入组 60 人开始时间: 2014年10月16日最近更新: 2023年9月26日

试验速览

暂无简介。

•1) Women, aged > 18 and < 65 years
•2) Epithelial ovarian peritoneal carcinomatosis (FIGO stage III c) of
•primary or recurrent diagnosis
•3) Radical cytoreductive surgery with HIPEC procedures peritonectomy and achieving optimal cytoreduction without macroscopic residue (R0)
•4) Body mass index (BMI) ? 30
•5) Classification ASA (American Society of Anesthesiologists) I-II
•6) Karnofsky Index> 70 or performance status <2
•7) Informed consent duly completed
•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 60
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1) Not meeting the inclusion criteria
•2) Presence of distant metastases or stage IV FIGO
•3) Coexistence of other malignant neoplasm
•4) Hepatic, renal or cardiovascular function altered
•5) More than 2 previous intravenous chemotherapy schemes
•6) Have received prior chemotherapy except intraperitoneal-diagnostic staging laparoscopy
•7) More than 2 previous surgical interventions ovarian neoplasia
•8) More than 2 complete bowel anastomosis
•9) Treatment intolerance
•10) Waiver of the patient to participate in the study

发起方

FUNDACIÓN PARA LA INVESTIGACIÓN BIOMÉDICA DE CÓRDOBA