Hyperthermic intra-peritoneal chemotherapy (HIPEC) in Ovarian cancer recurrence: Randomized trial on Survival Evaluation. - MITO 18

POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI0 sitesSeptember 28, 2012

Overview

No summary available.

Registry

who.int

Start Date

September 28, 2012

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI

•\-Age over 18 and under 70 years
•\-Patients affected by a first recurrence of ovarian cancer with measurable or not measurable lesions, but evaluable (upwards of Ca125 for 2 consecutive assessments).
•\-ECOG\-performance status \= 2
•\-Ovarian cancer limited to the abdominal cavity with or without extraperitoneal spread considered resectable at intraoperative evaluation
•\-Evidence of tumor recurrence diagnosed after 6 months from primary treatment
•\-Previous\-based chemotherapy of carboplatin and taxanes
•\-Peritoneal Washing\-positive in the presence of other abdominal disease surgically resectable
•\-Adequate respiratory, hepatic, cardiac, kidney and bone marrow function (absolute neutrophil count\> 1500 / mm3, platelets\> 150 000/µl, creatinine clearance\> 60 mL / min according to Cockroft formula)
•\-Patient\-compliant and psychologically able to follow the trial procedures
•Are the trial subjects under 18? no

•\-Non\-epithelial ovarian cancer or borderline ovarian tumor
•\-Pregnancy or breastfeeding
•\-Patients affected by major depressive disorder even in treatment or minor mood disorders
•\-Patients with severe impairment of respiratory, hepatic or renal function
•\-Patients with cardiac, neurological or metabolic uncontrolled pharmacologically disease
•\-Patients with active infection or other neoplastic disease in progress
•\-Patients with bowel obstruction
•\-Inadequate bone marrow, liver, kidney function
•\-No clear\-peritoneal disease at surgical exploration
•\-Patients with ascites\> 500 ml (the TAC)