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临床试验/NCT04234243
NCT04234243已完成不适用

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 个研究点目标入组 144 人开始时间: 2007年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
144
主要终点
free overall survival

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 72 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • without carcinomatosis

结局指标

主要结局

free overall survival

时间窗: 10 years

survillance from HIPEC procedure/IV chemotherapy for carcinomatosis, to death date or last consultation (months) Kaplan Meier curve

free recurrence survival

时间窗: 10 years

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

次要结局

  • factors associated with survival(10 years)

研究者

发起方
Instituto de Seguridad Social del Estado de Mexico y Municipios
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Juan Manuel Medina Castro

Peritoneal Malignacy neoplasm coordinator

Instituto de Seguridad Social del Estado de Mexico y Municipios

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