NCT04234243

HIPEC in Ovarian Cancer, Case-Controls Study With 10-years Follow up

HIPEC in Ovarian Cancer: The First Case Control Study in Mexican Patients With 10-year Follow-up

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 144 (actual)
• Sponsor: Instituto de Seguridad Social del Estado de Mexico y Municipios · Other Government
• Sex: Female
• Age: 18 Years – 72 Years
• Healthy volunteers: Not accepted

Summary

Objectives: Compare overall survival (OS) and progression-free survival (PFS) among ovarian cancer patients who underwent into cytoreduction and HIPEC procedure vs patients who only received systemic chemotherapy in a 10-years follow up of a case-control study Methods: Cases were defined as patients treated by cytoreduction and HIPEC, and were matched (1:2) with patients treated with chemotherapy only, defined as controls. PFS and OS in the two groups were measured and compared. PFS was calculated from initiation of treatment to progression, death or to the last known follow-up. OS was calculated from initiation of treatment to death or to the last known follow-up.

Detailed description

Epithelial ovarian cancer has the highest mortality of all gynecologic tumors in the world wide. Patients are diagnosed with International Federation of Gynecology and Obstetrics (FIGO) stage III to IV disease in 75%. The 10-year survival of women with advanced-stage ovarian cancer is 10% to 15% and has not improve in the past 20 years. Despite treatment with maximal cytoreductive surgery (CRS) and platinum-based chemotherapy, approximately 70% of patients with advanced-stage disease relapse within 18 months. Given this high number of recurrences, new approaches are needed to improve outcomes for these patients. Historically, peritoneal carcinomatosis represents a devastating form of cancer progression with a very poor prognosis. Objectives: Compare overall survival (OS) and progression-free survival (PFS) among ovarian cancer patients who underwent into cytoreduction and HIPEC procedure vs patients who only received systemic chemotherapy in a 10-years follow up of a case-control study Methods: Cases were defined as patients treated by cytoreduction and HIPEC, and were matched (1:2) with patients treated with chemotherapy only, defined as controls. PFS and OS in the two groups were measured and compared. PFS was calculated from initiation of treatment to progression, death or to the last known follow-up. OS was calculated from initiation of treatment to death or to the last known follow-up.

Conditions

• Ovarian Cancer
• HIPEC

Interventions

Type	Name	Description
PROCEDURE	cytoreduction and HIPEC	cytoreduction CCR 0-1, and HIPEC close technique

Timeline

• Start date: 2007-08-01
• Primary completion: 2017-12-31
• Completion: 2019-08-31
• First posted: 2020-01-21
• Last updated: 2020-01-29