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

Maimónides Biomedical Research Institute of Córdoba

Status and phase: Completed; Phase 2

Conditions: Peritoneal Carcinomatosis

Treatments: Drug: Paclitaxel; Procedure: Radical surgery-peritonectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02739698

PI 0678-10

Details and patient eligibility

About

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

Enrollment: 32 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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32 participants in 2 patient groups

normothermic (36-37ºC)

Experimental group

Description:

Group 1, n=16(normothermic): Intraperitoneal administration of 60 mg/m2 paclitaxel per 2 liters of 1.5% dextrose in room temperature (36-37ºC).

Treatment:

Procedure: Radical surgery-peritonectomy

Drug: Paclitaxel

hyperthermic (41-42ºC)

Experimental group

Description:

Group 2, n=16 (hyperthermic): Intraperitoneal administration of 60 mg/m2 paclitaxel per 2 liters of 1.5% dextrose in continuous hyperthermic perfusion (41-42ºC).

Treatment:

Procedure: Radical surgery-peritonectomy

Drug: Paclitaxel