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

January 27, 2020 updated by: Juan Manuel Medina Castro, Instituto de Seguridad Social del Estado de Mexico y Municipios

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

144

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 72 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

HIPEC population: 46 patients No HIPEC population : 92 patients

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HIPEC
women, with ovarian cancer stage III-IV or recurrent with carcinomatosis treated with cytoreduction and HIPEC
Procedure: cytoreduction and HIPEC
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
free overall survival
Time Frame: 10 years
survillance from HIPEC procedure/IV chemotherapy for carcinomatosis, to death date or last consultation (months) Kaplan Meier curve
10 years
free recurrence survival
Time Frame: 10 years
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
Time Frame: 10 years
histological and clinical factors associated with survival. uni and multivariate analysis (X2, Cox, U Mann-Witney)
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Seguridad Social del Estado de Mexico y Municipios

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2007

Primary Completion (ACTUAL)

December 31, 2017

Study Completion (ACTUAL)

August 31, 2019

Study Registration Dates

First Submitted

January 10, 2020

First Submitted That Met QC Criteria

January 15, 2020

First Posted (ACTUAL)

January 21, 2020

Study Record Updates

Last Update Posted (ACTUAL)

January 29, 2020

Last Update Submitted That Met QC Criteria

January 27, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COE-UEI/05/PT/2016

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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