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临床试验/NCT04879953
NCT04879953已完成不适用

Effect of Pressurised Intraperitoneal Aerosol Chemotherapy on the Survival Rate of Patients With Peritoneal Carcinomatosis of Gastric Origin

Association Francaise de Chirurgie1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2020年2月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
46
试验地点
1
主要终点
Overall survival at 6 months

研究概览

简要总结

Pressurised intraperitoneal aerosol chemotherapy is a new surgical technique, developed for the treatment of initially unresectable peritoneal carcinomatosis. The objective of this study was to compare the results of PIPAC associated with systemic chemotherapy with those of systemic chemotherapy alone in patients with gastric peritoneal carcinomatosis without metastasis other than peritoneal, and WHO performance status <3.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

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

入选标准

  • Patients 18 years or over
  • Patients with adenocarcinoma-type gastric non-resectable péritonéale carcinomatosis.
  • Patients without metastasis other than peritoneal.
  • WHO performance status <3
  • Patients treated either with PIPAC administered in alternation with systemic chemotherapy (PIPAC_CHEM) or by systemic chemotherapy alone (ONLY_CHEM)
  • Patient informed

排除标准

  • Patients opposed

研究组 & 干预措施

PIPAC CHEM

PIPAC associated with systemic chemotherapy

干预措施: PIPAC with systemic chemotherapy (Drug)

ONLY CHEM

systemic chemotherapy alone

干预措施: Systemic chemotherapy alone (Drug)

结局指标

主要结局

Overall survival at 6 months

时间窗: 6 months

Overall survival at 6 months from diagnosis of carcinomatosis

次要结局

  • Duration of hospital stay(6 months)
  • overall survival from the diagnosis of carcinomatosis and from the diagnosis of the primary tumour.(3 years)

研究者

发起方
Association Francaise de Chirurgie
申办方类型
Other
责任方
Principal Investigator
主要研究者

Pr Catherine Arvieux

Professeur

Association Francaise de Chirurgie

研究点 (1)

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