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临床试验/NCT01307878
NCT01307878已完成3 期

Pre-operation Chemotherapy of Primary Tumor Resection for Colorectal Cancer Patients With Asymptomatic Resectable Primary Lesion and Synchronous Unresectable Liver-limited Metastases

Fudan University1 个研究点 分布在 1 个国家目标入组 320 人开始时间: 2012年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
320
试验地点
1
主要终点
Progression-free survival

研究概览

简要总结

To evaluate the survival benefit of pre-operation chemotherapy of primary tumor tesection (PTR) compared upfront PTR for colorectal cancer (CRC) patients with an asymptomatic resectable primary tumor and synchronous unresectable liver-limited metastases with conversion therapy intent.

详细描述

Fast recovery with fewer postoperative complications, prevention of potential tumor-related complications during chemotherapy, life quality improvement, and also can alleviate the tumor load of patients, are some advantages of PTR that may play a role in improving cancer-specific survival. However, it should be pointed out that nearly all the retrospective and prospective studies for the beneficial of PTR enrolled more multi-organ metastases mCRC patients, and with palliative treatment purpose. As for unresectable colorectal liver-limited metastases (CRLMs) with good Eastern Cooperative Oncology Group performance status (ECOG PS), the primary objective is to make metastases resectable by high-intensity conversion therapy and achieved a state of no-evidence of disease. PTR were preferred performed before enrollment in some related RCT studies, including the CELIM study, CAIRO and CAIRO2 studies. Pooled-analysis of our two RCT studies, PTR pre or post chemotherapy for these unresectable liver-limited metastases patients had less morbidities and no mortalities, but no RCTs have focused on survival benefit of pre-operation chemotherapy of PTR for unresectable CRLMs.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age between 18 - 75 years old
  • colorectal adenocarcinoma pathologically
  • without any chemotherapy or radiotherapy
  • unresectable liver metastasis and without other metastasis
  • resectable colorectal cancer
  • suitable for chemotherapy
  • agreed by patients

排除标准

  • age below 18 years old or greater than 75 years old
  • haven't pathological diagnosis of colorectal adenocarcinoma
  • with any chemotherapy or radiotherapy
  • resectable liver metastasis or without other metastasis
  • unresectable colorectal cancer
  • unsuitable for chemotherapy
  • not agreed by patients

研究组 & 干预措施

arm A

Experimental

Pre-PTR, chemotherapy regimen with either mFOLFOX6 plus cetuximab, bevacizumab or mFOLFOX6 alone were allocated, according the RAS genotype and patient affordability.

干预措施: chemotherapy ± targeted therapy (Drug)

结局指标

主要结局

Progression-free survival

时间窗: Up to 3 years

Time from randomization to the date of disease progression or to death of any cause

次要结局

  • Tumor response(Up to 6 months)
  • Surgical complications(30 days after surgery)
  • Overall survival(Up to 3 years)
  • Secondary resection rate Second radical resectability(Up to 6 months)
  • Toxicity of chemotherapy(Up to 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Xu jianmin

Professor

Fudan University

研究点 (1)

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