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

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04234243
• Other study ID #: COE-UEI/05/PT/2016
• Status: Completed
• Start date: August 1, 2007
• Est. completion date: August 31, 2019

Study information

• Verified date: January 2020
• Source: Instituto de Seguridad Social del Estado de Mexico y Municipios
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: August 31, 2019
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 72 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• HIPEC
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Procedure:
• cytoreduction and HIPEC
cytoreduction CCR 0-1, and HIPEC close technique

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Seguridad Social del Estado de Mexico y Municipios

Outcome

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