Overview

This trial is active, not recruiting.

Condition peritoneal carcinomatosis
Treatments paclitaxel, radical surgery-peritonectomy
Phase phase 2
Sponsor Maimónides Biomedical Research Institute of Córdoba
Start date July 2012
End date November 2014
Trial size 32 participants
Trial identifier NCT02739698, PI 0678-10

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Arm
(Experimental)
Group 1, n=16(normothermic): Intraperitoneal administration of 60 mg/m2 paclitaxel per 2 liters of 1,5% dextrose in room temperature (36-37ºC).
paclitaxel
radical surgery-peritonectomy
(Experimental)
Group 2, n=16 (hyperthermic): Intraperitoneal administration of 60 mg/m2 paclitaxel per 2 liters of 1,5% dextrose in continuous hyperthermic perfusion (42-43ºC).
paclitaxel
radical surgery-peritonectomy

Primary Outcomes

Measure
Pathological response change (Miller & Payne System )
time frame: 60 minutes

Eligibility Criteria

Female participants from 18 years up to 75 years old.

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.

Additional Information

Official title Role of Intraperitoneal Intraoperative Chemotherapy With Paclitaxel in the Surgical Treatment of Peritoneal Carcinomatosis From Ovarian Cancer. Hyperthermia Versus Normothermia
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Maimónides Biomedical Research Institute of Córdoba.