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Completed

NCT Number: NCT04234243

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cytoreduction and HIPEC

Procedure

cytoreduction CCR 0-1, and HIPEC close technique

Primary outcomes

  1. 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

  2. free recurrence survival

    Time frame: 10 years

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

Secondary outcomes

  1. factors associated with survival

    Time frame: 10 years

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

Sponsors and collaborators

Lead sponsor

Instituto de Seguridad Social del Estado de Mexico y Municipios

Other Gov

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2017
Study completion
2019
First posted
Jan 21, 2020
Registry last updated
Jan 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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