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

Study Overview
=================
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.

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

Conditions
-----------------
Ovarian Cancer, HIPEC

Intervention / Treatment
-----------------
* Procedure: cytoreduction and HIPEC


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 72 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HIPEC<br>women, with ovarian cancer stage III-IV or recurrent with carcinomatosis treated with cytoreduction and HIPEC | Procedure: cytoreduction and HIPEC<br>* cytoreduction CCR 0-1, and HIPEC close technique<br>|
| No HIPEC<br>women, with ovarian cancer stage III-IV or recurrent with carcinomatosis, treated with systemic chemotherapy only | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| free overall survival | survillance from HIPEC procedure/IV chemotherapy for carcinomatosis, to death date or last consultation (months) Kaplan Meier curve | 10 years | 
| free recurrence survival | survillance from HIPEC procedure/IV chemotherapy for carcinomatosis, to recurrence date (months) Kaplan Meier curve | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| factors associated with survival | histological and clinical factors associated with survival. uni and multivariate analysis (X2, Cox, U Mann-Witney) | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIPEC