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

Conditions: Ovarian cancer
MedDRA version: 14.1Level: PTClassification code 10033128Term: Ovarian cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2012-002872-15-IT

Lead Sponsor: POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: Not specified

Inclusion Criteria

-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
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 130
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 28

Exclusion Criteria

-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)
-Patients on maintenance therapy with Antiangiogenic
-Patients with secondary or tertiary recurrence, or already submitted to HIPEC
-Patients who have already made the second or third line chemotherapy.