Clinical trial NCT04234243: HIPEC in Ovarian Cancer, Case-Controls Study With 10-years Follow up
Official title: HIPEC in Ovarian Cancer: The First Case Control Study in Mexican Patients With 10-year Follow-up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Cancer
HIPEC
Keywords: HIPEC
Lead sponsor: Instituto de Seguridad Social del Estado de Mexico y Municipios
Sponsor class: OTHER_GOV
First posted: 2020-01-21
Enrollment: 144
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIPEC population: 46 patients No HIPEC population : 92 patients

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.

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

Primary outcomes:
measure: free overall survival
timeFrame: 10 years
measure: free recurrence survival
timeFrame: 10 years
Secondary outcomes:
measure: factors associated with survival
timeFrame: 10 years
Other outcomes:
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Study officials:
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