Role of Intraperitoneal Intraoperative Chemotherapy With Paclitaxel in the Surgical Treatment of Peritoneal Carcinomatosis From Ovarian Cancer. Hyperthermia Versus Normothermia
This trial is active, not recruiting.
|Treatments||paclitaxel, radical surgery-peritonectomy|
|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|
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
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (outcomes assessor)|
Pathological response change (Miller & Payne System )
time frame: 60 minutes
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.
|Official title||Role of Intraperitoneal Intraoperative Chemotherapy With Paclitaxel in the Surgical Treatment of Peritoneal Carcinomatosis From Ovarian Cancer. Hyperthermia Versus Normothermia|
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