NCT02681432

Hyperthermic Intraperitoneal Chemotherapy With Paclitaxel in Advanced Ovarian Cancer

Hyperthermic Intraperitoneal Chemotherapy With Paclitaxel for the Treatment of Patients With Recurrent or Primary Advanced Ovarian Cancer : A Randomised Phase 3 Study

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: PEDRO VILLAREJO CAMPOS · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Randomized clinical trial to asses the efficacy of closed abdomen hyperthermia intraperitoneal chemotherapy with paclitaxel in ovarian cancer.

Detailed description

Randomized clinical trial performed in woman with epithelial primary ovarian cancer (stage FIGO II, III and IV) or tumor recurrence. A cytoreductive surgery will be perform in all of the patients include in the trial, and it will be assign at randomization: * HIPEC-arm: cytoreductive surgery and hyperthermic intraperitoneal chemotherapy with paclitaxel (175 mg / m2) for 60 minutes at a temperature of 42-43º degrees; followed by postoperative systemic IV chemotherapy with carboplatin (AUC=6) and paclitaxel (175 mg/m2) for 6 cycles. * No HIPEC-arm: Cytoreductive surgery followed by postoperative systemic IV chemotherapy with carboplatin (AUC=6) and paclitaxel (175 mg/m2) for 6 cycles.

Conditions

• Epithelial Ovarian Cancer

Interventions

Type	Name	Description
DRUG	HIPEC	Cytoreductive surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with Paclitaxel (175 mg/m2) for 60 minutes at 42-43 degrees.
PROCEDURE	No HIPEC	Cytoreductive surgery without HIPEC

Timeline

• Start date: 2012-01-01
• Primary completion: 2019-09-01
• Completion: 2019-12-01
• First posted: 2016-02-12
• Last updated: 2018-08-21

Locations

1 site across 1 country: Spain