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 sites60 target enrollmentOctober 16, 2014

Overview

No summary available.

Registry

who.int

Start Date

October 16, 2014

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

FUNDACIÓN PARA LA INVESTIGACIÓN BIOMÉDICA DE CÓRDOBA

•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:

•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