A Phase II Study of Neoadjuvant FOLFOX6 Plus Cetuximab in Patients With Colorectal Cancer and Unresectable Liver Metastasis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- To evaluate overall R0 resection rates following neoadjuvant FOLFOX6 plus cetuximab in patients with colorectal cancer and unresectable liver-only metastasis
研究概览
简要总结
An innovative therapeutic strategy to increase the complete resection rate is of utmost importance in order to enhance survival in colorectal cancer patients with unresectable liver-only metastasis. Therefore, the investigators propose a prospective study of neoadjuvant chemotherapy using FOLFOX6 plus cetuximab to convert initially unresectable liver metastasis to potentially resectable disease.
详细描述
We will include the patients with unresectable liver-only metastatic disease independent of EGFR status. The results of this study will show the resection rate with neoadjuvant treatment in patients with colorectal cancer with liver-only metastasis.
Restaging including CT after #3, #6, #9, and #12 cycles of FOLFOX + Cetuximab
If any time, patients have PD, Off-study SD, Continue study treatment until resectable, up to #12 cycles, PD, or toxicities PR or more, If resectable, go to surgery : resection of liver metastasis and primary tumor, if present If unresectable, continue until resectable, up to #12 cycles, PD, or toxicities
Overall, a total of 12 cycles of treatment including neoadjuvant therapy will be given either before, after or without surgery.
CT scans will be performed every 3 cycles during the first 12 cycles (6 months). After that, CT scans will be performed every 2 months for another 6 months, then every 3 months for 6 months, then once a year or earlier if a PD is probable.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven colorectal cancer with metastatic lesion(s) in the liver that is (are) unresectable
- •ECOG performance 0 - 1
- •Adequate organ function ((hepatic transaminases ≤ 5x upper limit of normal, bilirubin < 2.0 x upper limit of normal, and creatinine ≤ 1.5x upper limit of normal, platelet > 100,000/ul, absolute neutrophil count ≥ 1,500/ul)
- •At least one measurable lesion by RECIST criteria
- •Written informed consent
排除标准
- •Resectable liver metastasis
- •Extrahepatic metastases, regardless of their resectability
- •Chronic active hepatitis or cirrhosis
- •Prior therapy for metastatic disease
- •Pregnant or lactating women
- •Uncontrolled medical illnesses including medically uncontrolled infection, uncontrolled hypertension, unstable angina, symptomatic congestive heart failure, myocardial infarction within 6 months
- •Previous adjuvant FOLFOX chemotherapy
- •Prior adjuvant chemotherapy, if administered within 6 months before study entry
- •Known hypersensitivity reaction to any of the components of study treatment
- •Prior agents directed against EGFR
- •Prior allergic reaction (known sensitivity) to chimerized or murine monoclonal antibody therapy
- •Known alcohol or drug abuse
- •Participation in another clinical study within the 30 days before registration
- •Peripheral neuropathy > grade 1
- •Other previous malignancy with exception of a history of a previous curatively treated basal cell carcinoma of the skin of pre-invasive carcinoma of the cervix.
研究组 & 干预措施
NEO
NEO : Neoadjuvant therapy with FOLFOX6 plus cetuximab
干预措施: FOLFOX6/cetuximab (Drug)
结局指标
主要结局
To evaluate overall R0 resection rates following neoadjuvant FOLFOX6 plus cetuximab in patients with colorectal cancer and unresectable liver-only metastasis
时间窗: 18 months
次要结局
- Response rate (according to RECIST)(24 months)
- Progression-free survival time(24 months)
- Overall survival timeToxicity profile (according to NCI CTCAE v3)(24 months)
- Correlative analyses between pretreatment EGFR, KRAS mutation and response rate/survival(24 months)
研究者
Young Suk Park
Professor
Samsung Medical Center