Role of Intraperitoneal Intraoperative Chemotherapy With Paclitaxel in the Surgical Treatment of Peritoneal Carcinomatosis From Ovarian Cancer. Hyperthermia Versus Normothermia

• Status: Completed
• Trial end date: 2017-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

A randomized controlled single-blind clinical trial was performed, in 32 patients diagnosed with peritoneal carcinomatosis from epithelial ovarian cancer, who underwent radical surgery-peritonectomy, achieving an optimal R0-R1 cytoreduction (microscopic tumor residues (R0) or macroscopic tumor residues < 1cm (R1)) followed by hyperthermia against normothermia intraperitoneal intraoperative chemotherapy with paclitaxel

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Maimónides Biomedical Research Institute of Córdoba
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

Criteria

Inclusion Criteria:

1. age ranged between 18 and 75 years old;

2. histopathologic confirmation of peritoneal carcinomatosis from epithelial ovarian cancer (stage IIIc- FIGO (International Federation of Gynecology and Obstetrics));

3. Karnofsky index > 70 or performance status ≤2;

4. informed consent form filled out correctly.

Exclusion Criteria:

1. unfulfillment of inclusion criteria;

2. extraabdominal metastasis or stage IV FIGO (liver, lung, bone, etc);

3. concomitance of another malignant neoplasm;

4. renal, hepatic or cardiovascular dysfunction;

5. intolerance during the treatment; - (6) refusal to participate in the study.