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

Completed

• Conditions: Ovarian Cancer; HIPEC
• Interventions: Procedure: cytoreduction and HIPEC

• Registration Number: NCT04234243
• Lead Sponsor: Instituto de Seguridad Social del Estado de Mexico y Municipios

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.

Study Timeline

• Study Start: 2007-08-01
• Primary Completion: 2017-12-31
• Study Completion: 2019-08-31
• Status Verified: 2020-01
• Study First Submitted: 2020-01-10
• Study First Submitted QC: 2020-01-15
• Study First Posted: 2020-01-21
• Last Update Submitted: 2020-01-27
• Last Update Posted: 2020-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 144

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
free overall survival	10 years	survillance from HIPEC procedure/IV chemotherapy for carcinomatosis, to death date or last consultation (months) Kaplan Meier curve
free recurrence survival	10 years	survillance from HIPEC procedure/IV chemotherapy for carcinomatosis, to recurrence date (months) Kaplan Meier curve

Secondary Outcome Measures

Name	Time	Method
factors associated with survival	10 years	histological and clinical factors associated with survival. uni and multivariate analysis (X2, Cox, U Mann-Witney)