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临床试验/NCT04513457
NCT04513457已完成不适用

Perioperative Chemotherapy Versus Surgery for Resectable Colorectal Liver Metastases: a Multicenter Propensity Score Matched Analysis on Long-term Outcomes

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa9 个研究点 分布在 3 个国家目标入组 967 人开始时间: 2010年1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
967
试验地点
9
主要终点
Peri-operative morbidity

研究概览

简要总结

There is a degree of uncertainty regarding the role of perioperative chemotherapy (CTx) in the treatment of resectable colorectal liver metastases (CRLM). In the clinical practice, the combination of surgery and CTx is increasingly accepted as treatment for CRLM, especially in the context of patients with synchronous disease or metachronous disease with a high risk of recurrence. However, controversy exists whether all patients with resectable CRLM benefit from perioperative CTx.

There is paucity of good quality studies on this topic. A pooled analysis of two phase III randomized clinical trial, closed prematurely because of slow accrual, showed a marginal statistical significance in favor of adjuvant CTx. Nevertheless, long term results of the EPOC trial founded benefit in disease free survival (DFS) with no difference in overall survival (OS) when perioperative CTx with FOLFOX4 was compared with surgery alone for resectable CRLM. Furthermore, a retrospective series from Ayez et al showed that patients with a high CRS benefit from neo-adjuvant CTx while in patients with a low risk profile did not. On the other side, another retrospective series from the MSKCC showed the timing of additional CTx for resectable CRLM was not associated with improved outcomes. The ongoing CHARISMA trial is currently comparing the outcomes of neo-adjuvant CTx followed by surgery versus surgery alone in high-risk patients with resectable CRLM.

This uncertainty regarding CRLM management may partly be due to the fact that these studies are not well powered to detect minor differences in long term outcomes and they often involved a very heterogenous group of patients with both synchronous and metachronous CRLM, not stratified by clinical risk score (CRS) as described by Fong et al.

研究设计

研究类型
Observational
观察模型
Cohort
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 older than 18 years with resectable liver metastases of histologically confirmed primary colorectal carcinoma.
  • Minimum follow-up of five years.

排除标准

  • Patients with extrahepatic disease

结局指标

主要结局

Peri-operative morbidity

时间窗: 5 years of follow-up

Peri-operative morbidity

Overall survival based on perioperative treatment

时间窗: 5 years of follow-up

Overall survival based on perioperative treatment

Disease-free survival based on perioperative treatment

时间窗: 5 years of follow-up

Disease-free survival based on perioperative treatment

Cancer survival based on perioperative treatment

时间窗: 5 years of follow-up

Cancer survival based on perioperative treatment

Peri-operative mortality

时间窗: 5 years of follow-up

Peri-operative mortality

次要结局

  • Overall survival, cancer survival and disease-free survival related with biological markers(5 years of follow-up)
  • Overall survival, cancer survival and disease-free survival based related with simultaneous thermal ablation performed at the same time of the surgical excision.(5 years of follow-up)
  • Overall survival, cancer survival and disease-free survival related with hidden no resected liver lesions.(5 years of follow-up)

研究者

发起方
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
申办方类型
Other
责任方
Sponsor

研究点 (9)

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