A Multicenter Study of Prognosis and the Efficacy Comparison of Perioperative Chemotherapy Plus Cetuximab Versus Chemotherapy Alone for High Risk Patients(Clinical Risk Score≥3) of Resectable Colorectal Liver Metastasis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 135
- 试验地点
- 4
- 主要终点
- disease free survival
研究概览
简要总结
This study was designed to analyze the prognosis and recurrence predictive factors of high risk patients (Clinical Risk Score≥3) of resectable colorectal liver metastasis.
The efficacy of perioperative chemotherapy plus cetuximab and chemotherapy alone was compared for these patients.
详细描述
Resection could prolong the survival of colorectal liver metastasis patients, however,the curative resection rate was still low and more than 2/3 of the patients would experience tumor recurrence.This study was designed to formulate a more accurate and individual evaluation system via the multivariate analysis.
Up to now, there was no data to demonstrate the addition of cetuximab to perioperative chemotherapy could decrease recurrence and prolong survival for RAS wild-type, high risk(Clinical Risk Score≥3) resectable colorectal liver metastasis patients. This study was also designed to elucidate this question and to observe the objective response rate(ORR) and the safety data of the regime.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •good performance status
- •pathologic diagnosis of colorectal cancer
- •Rat sarcoma viral oncogene homolog(RAS) wild-type
- •radiologic confirmation the resectability of liver metastases
- •enough future liver remnant
- •Clinical Risk Score≥3
- •treatment naive
- •extra-hepatic metastases could be resected completely, if exist
排除标准
- •poor performance status, could not tolerate chemotherapy or operation
- •other malignancy history or synchronously
- •extra-hepatic metastases could not be resected completely, if exist
- •received other treatment previously
研究组 & 干预措施
chemotherapy plus cetuximab
Cetuximab plus FOLFIRI/FOLFOX:FOLFIRI plus cetuximab [Irinotecan 180 mg/m2 IV over 30-90 minutes, day 1;Leucovorin 400 mg/m2 IV infusion to match duration of irinotecan infusion, day 1;5-fluoruracil(5-FU) 400 mg/m2 IV bolus day 1, then 1200 mg/m2/day x 2 days (total 2400 mg/m2 over 46-48 hours) IV continuous infusion.Repeat every 2 weeks.Cetuximab 500 mg/m2 IV over 2 hours, day 1, every 2 weeks] or FOLFOX plus Cetuximab [Oxaliplatin 85 mg/m2 IV over 2 hours, day 1 Leucovorin 400 mg/m2 IV over 2 hours, day 1 5-FU 400 mg/m2 IV bolus on day 1, then 1200 mg/m2/day x 2 days (total 2400 mg/m2 over 46-48 hours) IV continuous infusion Repeat every 2 weeks;Cetuximab 500 mg/m2 IV over 2 hours, day 1, every 2 weeks]
干预措施: Cetuximab plus FOLFIRI/FOLFOX (Drug)
perioperative chemotherapy alone
FOLFIRI/FOLFOX/CapeOX:routine perioperative chemotherapy including FOLFIRI[Irinotecan 180 mg/m2 IV over 30-90 minutes, day 1 Leucovorin 400 mg/m2 IV infusion to match duration of irinotecan infusion, day 1 5-FU 400 mg/m2 IV bolus day 1, then 1200 mg/m2/day x 2 days (total 2400 mg/m2 over 46-48 hours) continuous infusion Repeat every 2 weeks] or FOLFOX[Oxaliplatin 85 mg/m2 IV over 2 hours, day 1;Leucovorin 400 mg/m2 IV over 2 hours, day 1 5-FU 400 mg/m2 IV bolus on day 1, then 1200 mg/m2/day x 2 days (total 2400 mg/m2 over 46-48 hours) IV continuous infusion Repeat every 2 weeks] or CapeOX[Oxaliplatin 130 mg/m2 IV over 2 hours, day 1 Capecitabine 850-1000mg/m2 twice daily PO for 14 days Repeat every 3 weeks] was adopted in this control arm.
干预措施: FOLFIRI/FOLFOX/CapeOX (Drug)
结局指标
主要结局
disease free survival
时间窗: From date of hepatectomy until the date of first documented recurrence or metastasis or date of death from any cause, whichever came first, assessed up to 60 months
months the patient lived from the date of liver resection to the date of disease recurrence or metastasis
次要结局
- overall survival(From date of hepatectomy until the date of first documented death from any cause or the last follow-up if no death happened, assessed up to 60 months)
- objective response rate(from the date of the first chemotherapy until the date two weeks after the completion of the last preoperative chemotherapy, assessed up to 6 weeks)
研究者
Wang Kun
associate director
Peking University Cancer Hospital & Institute