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

NCT ID: NCT04234243

Last Updated: 2020-01-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 144 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-08-01
• Study Completion Date: 2019-08-31

Brief 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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

HIPEC

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

cytoreduction and HIPEC

Intervention Type: PROCEDURE

cytoreduction CCR 0-1, and HIPEC close technique

No HIPEC

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

No interventions assigned to this group

Interventions

cytoreduction and HIPEC

cytoreduction CCR 0-1, and HIPEC close technique

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 72 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Instituto de Seguridad Social del Estado de Mexico y Municipios

OTHER_GOV

Sponsor Role: lead

Responsible Party

Juan Manuel Medina Castro

Peritoneal Malignacy neoplasm coordinator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

COE-UEI/05/PT/2016

Identifier Type: -

Identifier Source: org_study_id