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

Instituto de Seguridad Social del Estado de Mexico y Municipios

Status: Completed

Conditions: HIPEC; Ovarian Cancer

Treatments: Procedure: cytoreduction and HIPEC

Study type: Observational

Funder types: Other

Identifiers

NCT04234243

COE-UEI/05/PT/2016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 144 patients

Sex: Female

Ages: 18 to 72 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of Epithelial ovarian cancer confirmed
• FIGO stage III-IV or carcinomatosis recurrence
• No comorbidities or controlled comorbidities
• ECOG 0-2

Exclusion criteria

• without carcinomatosis

Trial design

144 participants in 2 patient groups

HIPEC

Description:

women, with ovarian cancer stage III-IV or recurrent with carcinomatosis treated with cytoreduction and HIPEC

Treatment:

Procedure: cytoreduction and HIPEC

No HIPEC

Description:

women, with ovarian cancer stage III-IV or recurrent with carcinomatosis, treated with systemic chemotherapy only