cytoreduction and HIPEC
Procedurecytoreduction CCR 0-1, and HIPEC close technique
NCT Number: NCT04234243
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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Notify Me18 year–72 year
Female
Observational
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
cytoreduction CCR 0-1, and HIPEC close technique
Time frame: 10 years
survillance from HIPEC procedure/IV chemotherapy for carcinomatosis, to death date or last consultation (months) Kaplan Meier curve
Time frame: 10 years
survillance from HIPEC procedure/IV chemotherapy for carcinomatosis, to recurrence date (months) Kaplan Meier curve
Time frame: 10 years
histological and clinical factors associated with survival. uni and multivariate analysis (X2, Cox, U Mann-Witney)
Instituto de Seguridad Social del Estado de Mexico y Municipios
Other Gov
HIPEC in Ovarian Cancer: The First Case Control Study in Mexican Patients With 10-year Follow-up
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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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