Biomarker-Panel Enriched Maintenance Treatment With Cetuximab Monotherapy Versus Continuation After Induction Treatment With Chemotherapy + Cetuximab in Metastatic Colorectal Cancer (mCRC)
试验速览
- 阶段
- 2 期
- 入组人数
- 500
- 主要终点
- PFS
研究概览
简要总结
Investigating the efficacy of Cetuximab Monotherapy versus Continuation after induction treatment with chemotherapy + Cetuximab in inoperable or irresectable and non-progressive metastatic colorectal cancer after first line induction treatment for 24 weeks with mFOLFOX6/FOLFIRI and Cetuximab treatment. Reinduction treatment will be done in case of progression.
详细描述
Investigating the efficacy of Cetuximab Monotherapy versus Continuation after induction treatment with chemotherapy + Cetuximab in inoperable or irresectable and non-progressive metastatic colorectal cancer after first line induction treatment for 24 weeks with mFOLFOX6/FOLFIRI and Cetuximab treatment. Reinduction treatment will be done in case of progression. This treatment is continued until progression or severe toxicity.
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
- 是
入选标准
- •Histological proof of colorectal cancer (in case of a single metastasis, histological or cytological proof of this lesion should be obtained);
- •Distant metastases (patients with only local recurrence are not eligible);
- •Unidimensionally measurable disease (> 1 cm on spiral CT scan or > 2 cm on chest X-ray; liver ultrasound is not allowed). Serum CEA may not be used as a parameter for disease evaluation;
- •In case of previous radiotherapy, at least one measurable lesion should be located outside the irradiated field;
- •Ongoing or planned first line treatment with 6 cycles of mFOLFOX6/FOLFIRI plus Cetuximab.
- •At randomisation:
- •WHO performance status 0-1 (Karnofsky PS > 70%);
- •Laboratory values obtained ≤ 2 weeks prior to randomisation:
- •adequate bone marrow function (Hb > 6.0 mmol/L, absolute neutrophil count > 1.5 x 109/L, platelets > 100 x 109/L),
- •renal function (serum creatinine ≤ 1.5x ULN and creatinine clearance, Cockroft formula, > 30 ml/min),
- •liver function (serum bilirubin ≤ 2 x ULN, serum transaminases ≤ 3 x ULN without presence of liver metastases or ≤ 5x ULN with presence of liver metastases);
- •Negative pregnancy test in women with childbearing potential;
- •Expected adequacy of follow-up;
- •Institutional Review Board approval;
- •Written informed consent Exclusion criteria;
- •History or clinical signs/symptoms of CNS metastases;
- •History of a second malignancy ≤ 5 years with the exception of adequately treated carcinoma of cervix or basal/squamous cell carcinoma of skin.
排除标准
- •Prior adjuvant treatment for stage II/III colorectal cancer ending within 6 months before the start of induction treatment;
- •Any prior adjuvant treatment after resection of distant metastases;
- •Previous systemic treatment for advanced disease.
研究组 & 干预措施
Cet maintenance
Cetuximab maintenance treatment following induction treatment
干预措施: Cetuximab (Drug)
Cet+chemo continuation
Cetuximab plus continuation mFOLFOX6/FOLFIRI regimens
干预措施: Cetuximab (Drug)
Cet+chemo continuation
Cetuximab plus continuation mFOLFOX6/FOLFIRI regimens
干预措施: mFOLFOX6 (Drug)
Cet+chemo continuation
Cetuximab plus continuation mFOLFOX6/FOLFIRI regimens
干预措施: FOLFIRI (Drug)
结局指标
主要结局
PFS
时间窗: 4-6 months
次要结局
- QoL(22 months)
- OS(22 months)