Conditions: Peritoneal Carcinomatosis
Keywords: ovarian cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 32
Healthy volunteers: no

Brief 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

Detailed description:

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

Interventions: intervention 1: Paclitaxel intervention 2: Radical surgery-peritonectomy
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: