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Clinical Trials/NCT04234243
NCT04234243
Completed
Not Applicable

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

Instituto de Seguridad Social del Estado de Mexico y Municipios0 sites144 target enrollmentAugust 1, 2007

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ovarian Cancer
Sponsor
Instituto de Seguridad Social del Estado de Mexico y Municipios
Enrollment
144
Primary Endpoint
free overall survival
Status
Completed
Last Updated
6 years ago

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2007
End Date
August 31, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Instituto de Seguridad Social del Estado de Mexico y Municipios
Responsible Party
Principal Investigator
Principal Investigator

Juan Manuel Medina Castro

Peritoneal Malignacy neoplasm coordinator

Instituto de Seguridad Social del Estado de Mexico y Municipios

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • without carcinomatosis

Outcomes

Primary Outcomes

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

free recurrence survival

Time Frame: 10 years

survillance from HIPEC procedure/IV chemotherapy for carcinomatosis, to recurrence date (months) Kaplan Meier curve

Secondary Outcomes

  • factors associated with survival(10 years)

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