Pre-and Post-operative Cetuximab Plus mFOLFOX6 Versus mFOLFOX6 Alone in RAS/BRAF Wild Type Patients With High-Risk Resectable Colorectal Liver Metastases
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Event-free survival
研究概览
简要总结
For patients with initially resectable colorectal cancer liver metastases who have high-risk factors, neoadjuvant therapy is currently considered a consensus approach. However, there is ongoing debate regarding the optimal treatment strategy. Our study aims to investigate whether the addition of cetuximab to neoadjuvant chemotherapy improves outcomes compared to neoadjuvant chemotherapy alone. The objective of this phase III clinical trial is to determine whether the combination of cetuximab and mFOLFOX6 chemotherapy is superior to neoadjuvant mFOLFOX6 chemotherapy alone for patients with initially resectable colorectal cancer liver metastases who have wild-type RAS/BRAF and high-risk factors.
详细描述
Primary
• To determine whether the addition of cetuximab to neoadjuvant mFOLFOX6 chemotherapy results in improved event-free survival when compared with neoadjuvant mFOLFOX6 chemotherapy alone in patients with high-risk & RAS/BRAF-wild-type & resectable colorectal liver metastases.
Secondary
- To evaluate the overall survival of patients treated with these regimens.
- To evaluate the quality of life of patients treated with these regimens.
- To evaluate the preoperative remission rate, safety, surgical complications, actual resection rate, pathological resection status of patients treated with these regimens.
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
- Single (Outcomes Assessor)
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
- •Histological proof of colorectal adenocarcinoma;
- •Age ≥ 18 years and ≤75 years;
- •RAS wild type；
- •Simultaneous liver-limited metastases;
- •At least one measurable liver metastases;
- •World Health Organization (WHO) performance status 0-1;
- •Life expectancy ≥ 3 months;
- •Adequate hematologic function: absolute neutrophil count (ANC)≥1.5×109/l, platelets≥100×109/l, and hemoglobin(HB) ≥ 9g/dl;
- •Adequate liver and renal function: total bilirubin ≤2.0 mg/dl, serum transaminases ≤ 5x upper limit of normal(ULN), and serum creatinine ≤ 1.5x ULN and creatinine clearance ≥ 30 ml/min;
- •Written informed consent.
排除标准
- •Previous systemic treatment for metastatic disease;
- •Previous surgery for metastatic disease;
- •Extrahepatic metastases;
- •Unresectable primary tumor;
- •Major cardiovascular events (myocardial infarction, severe/unstable angina, congestive heart failure, CVA) within 12 months before randomisation;
- •Acute or subacute intestinal obstruction;
- •Second primary malignancy within the past 5 years;
- •Drug or alcohol abuse;
- •No legal capacity or limited legal capacity;
- •Pregnant or lactating women;
- •Uncontrolled hypertension, or unsatisfactory blood pressure control with ≥3 antihypertensive drugs;
- •Peripheral neuropathy;
研究组 & 干预措施
mFOLFOX6 + Cetuximab
Cetuximab + mFOLFOX6: Cetuximab (500mg/m2 IV ) will be given. Oxaliplatin (85 mg/m2 IV over 2 h on day 1), Leucovorin calcium (350 mg/m2 IV over 2 h on day 1) plus a bolus of 5FU (400 mg/m2) followed by a 46h-48h IV infusion of 5FU 2400 mg/m2 will be repeated for every 2 weeks. The regimens repeat every 2 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.
干预措施: mFOLFOX6 + Cetuximab (Drug)
mFOLFOX6
mFOLFOX6: Oxaliplatin (85 mg/m2 IV over 2 h on day 1), Leucovorin calcium (350 mg/m2 IV over 2 h on day 1) plus a bolus of 5FU (400 mg/m2) followed by a 46h-48h IV infusion of 5FU 2400 mg/m2 will be repeated for every 2 weeks. The regimens repeat every 2 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.
干预措施: mFOLFOX 6 (Drug)
结局指标
主要结局
Event-free survival
时间窗: 3 years
The Event-free survival (EFS) was defined as the period from the start of initial medication to the date of tumor relapse, progression, or death
次要结局
- overall survival(5 years)
- postoperative hospital stay(30 days post operatively)
- postoperative complication(After surgery during one month)
- postoperative mortality(After surgery during 90 days)
研究者
Xu jianmin
Director of the Department of Colorectal Surgery
Fudan University