跳至主要内容
临床试验/NCT03931304
NCT03931304已完成不适用

Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy in Peritoneal Carcinomatosis From Ovarian Cancer

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2018年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,200
试验地点
1
主要终点
Evaluation of 3-years disease free survival

研究概览

简要总结

Epithelial ovarian carcinoma (EOC) is one of the main cause of death from cancer in women in the Western world. It is often diagnosed at an advanced stage and the disease remains confined to the peritoneal cavity for much of its natural history. Despite a high rate of response to first-line therapy, about 20% of EOC are naturally resistant to platinum and about 2/3 of patients with initial response will recur within 5 years. Most tumour recurrences will develop resistance to systemic platinum over time. The prognosis of these patients with persistent or recurrence disease remains poor despite salvage therapy including alternative systemic chemotherapy and further cytoreductive surgery (CRS). Since twenty years, centers have pursued comprehensive CRS combined with Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for the management of peritoneal surface malignancies (PSM). This combined approach is the standard of care for the management of some rare peritoneal disease such as pseudomyxoma peritonei or peritoneal mesothelioma. EOC should be an ideal target for this loco-regional treatment, as most of its evolution remains confined to intraperitoneal cavity and because of its sensitivity to chemotherapy. Intraperitoneal chemotherapy has been shown to have significant efficacy in frontline EOC in 3 large randomized studies. Recently, French clinical guidelines have been edited to recommend CRS+HIPEC in patients with ovarian, tubal or primitive carcinomatosis FIGOI IIIC, initially not resectable (Grade B). HIPEC adds some advantages to this intraperitoneal chemotherapy: the hyperthermia effect with its direct cytotoxicity demonstrated in vitro, the synergistic effect with some anticancer agents and, the deliverance immediately following CRS, avoiding the problem of "cancer cell entrapment" by postoperative or posttherapeutic adhesions that limits distribution of chemotherapy agents to all sites. The use of HIPEC for EOC was reported into relatively small case-series from single institutions. Results from a single centre cannot be extrapolated to other centres because of the heterogeneity of patient's selection and HIPEC techniques.

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 95 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Confirmed peritoneal carcinomatosis from ovarian cancer
  • Metachronous/synchronous peritoneal carcinomatosis
  • Grade FIGO (International Federation of Gynecology and Obstetrics) III or IV
  • Peritoneal Cancer Index (PCI) available
  • Indication for cytoreductive surgery +/- HIPEC
  • Complete macroscopic cytoreduction: CCR (cytoreduction score) -0/1

排除标准

  • Non complete macroscopic cytoreduction: CCR (cytoreduction score) -2
  • Peritoneal mesothelioma, pseudomyxoma peritonei
  • Extra peritoneal metastases

结局指标

主要结局

Evaluation of 3-years disease free survival

时间窗: 3 years

From the date of cytoreductive surgery with Hyperthermic Intraperitoneal Chemotherapy to death or to the end of follow-up

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验