Hyperthermic Intraperitoneal Chemotherapy for Treatment of Relapsed Ovarian Cancer

This is an interventional other trial for Ovarian Cancer Recurrent Read More

Inclusion Criteria:

• Patients with diagnosis of recurrent epithelial ovarian carcinoma, peritoneal carcinoma, or fallopian tube carcinoma after 6 month since platinum-based chemotherapy (first recurrence) and are scheduled for secondary surgical evaluation/cytoreduction
• ECOG/WHO Performance score of 0 to 1
• Adequate respiratory, hepatic, cardiac, kidney and bone marrow function ( Hb >= 8 g/dl, absolute neutrophil count > 1500/mm3, platelets > 100,000/mm3, creatinine clearance > 60 mL/min according to Cockroft formula)
• Adequate renal function Creatinine ≤ 1.5 mg/dl, and adequate hepatic function Bilirubin ≤ 1.5 mg/dl and AST and ALT ≤ 80 IU/L
• Histological types feature would be serous, endometrioid, clear cell, undifferentiated carcinomas, transitional cell carcinoma, or mixed epithelial carcinoma
• No end organ function
• Patients must have less than or equal to 2.5 mm residual disease at the completion of the cytoreductive surgery to be eligible for the study
• Patient-compliant and psychologically able to follow the trial procedures, signature of informed consent.

Exclusion Criteria:

• Evidence of extensive retroperitoneal lymph node disease
• Neuropsychiatric disorders;
• Pregnancy or breast feeding.
• Subjects who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded
• Subjects with invasive malignancies or had any evidence of the other cancer present within the last 3 years. Prior radiation for localized cancer of the breast, head and neck, or skin are permitted, provided that it was completed more than 3 years prior to enrollment, and the subject remains free of recurrent or metastatic disease
• Subjects with active infection that requires parenteral antibiotics
• Tumors of low malignant potential, or non-invasive borderline tumors
• Patients with any underlying cardiac, pulmonary, metabolic, renal, hepatic or gastrointestinal conditions, chronic or latent infectious diseases, immune deficiency, or history, which in the opinion of the investigator, places the patient at an unacceptable risk for participation in the study
• Patient with extra-abdominal metastatic disease
• Known platinum (carboplatin or cisplatin) allergy
• Life expectancy < 3 months
• Still, it will not be considered for the HIPEC protocol those patients with unresectable disease (presence of invasive peritoneal implants inoperable or at high risk for resection in critical locations such as hepatic hilum, the mesenteric root, trunk celiac, mesentery, and several small implants the serosa of the small intestine) and / or with residual disease after cytoreduction greater than or equal to 2.5 mm (CC-2 and CC-3).