A Randomised, Open-label Phase II Study Evaluating the Efficacy and Safety of Folfox6 + Cetuximab as First-line Therapy in Patients With Metastatic Colorectal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 26
- 主要终点
- the percentage of patients surviving without disease progression in each arm at 9 months
研究概览
简要总结
In Patients with metastatic colorectal cancer the following treatments first-line Folfiri+Cetuximab first-line Folfox6 + Cetuximab will be concerning efficacy and safety.
The trial compares Folfiri + Cetuximab and Folfox6 + Cetuximab concerning efficacy and safety as first
详细描述
The multicenter randomized phase II study will enroll a target of approximately 150 first-line patients with metastatic CRC.
EGFR expression is not required for study entry, however, the EGFR status will be measured retrospectively.
Patients are randomized to Arm A or Arm B. Arm A: FOLFOX 6 in combination with cetuximab Arm B: FOLFIRI in combination with cetuximab. Both efficacy and safety data will be collected. The investigators will assess response to treatment at 6 weeks, 12 weeks and thereafter every 12 weeks based on imaging Following permanent treatment cessation (stop of all study treatments) patients will be followed-up for.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum
- •Metastatic colorectal carcinoma not suitable for curative-intent resection
- •Availability of tumor sample (or able and willing to provide tumor sample) for EGFR assessment
- •Presence of at least one lesion measurable unidimensional by CT scan or MRI (Target lesion(s) must not lie within an irradiated area)
- •ECOG performance status of < 2 at study entry
排除标准
- •Brain metastasis (known or suspected)
- •Previous chemotherapy for metastatic CRC or adjuvant therapy with oxaliplatin or irinotecan. Adjuvant therapy with 5 FU or derivatives is allowed if the chemotherapy treatment free interval is > 6 months
- •Surgery (excluding diagnostic biopsy) or irritation within 4 weeks prior to study entry
- •Cocurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol
- •Any investigational agent(s) within 4 weeks prior to entry
- •Previous exposure to EGFR-pathway targeting therapy
研究组 & 干预措施
FOLFOX 6
FOLFOX 6:
- Oxaliplatin 100 mg/m² d1 concurrent with
- Leucovorin 400 mg/m², followed by
- Bolus 5FU 400 mg/m² , followed by
- Infusional 5FU 2400 mg/m² over 46 hours, every 2 weeks:
干预措施: Cetuximab, Oxaliplatin, Leucovorin, 5FU, Irinotecan (Drug)
FOLFOX 6
FOLFOX 6:
- Oxaliplatin 100 mg/m² d1 concurrent with
- Leucovorin 400 mg/m², followed by
- Bolus 5FU 400 mg/m² , followed by
- Infusional 5FU 2400 mg/m² over 46 hours, every 2 weeks:
干预措施: FOLFOX 6 (Drug)
FOLFIRI
FOLFIRI:
- Irinotecan 180 mg/m² day 1 concurrent with
- Leucovorin 400 mg/m² followed by
- Bolus 5FU 400 mg/m², followed by
- Infusional 5FU 2400 mg/m² over 46 hours, every 2 weeks
干预措施: Cetuximab, Oxaliplatin, Leucovorin, 5FU, Irinotecan (Drug)
FOLFIRI
FOLFIRI:
- Irinotecan 180 mg/m² day 1 concurrent with
- Leucovorin 400 mg/m² followed by
- Bolus 5FU 400 mg/m², followed by
- Infusional 5FU 2400 mg/m² over 46 hours, every 2 weeks
干预措施: FOLFIRI (Drug)
结局指标
主要结局
the percentage of patients surviving without disease progression in each arm at 9 months
次要结局
- PFS rates at 3,6,12 months
- Response rates
- Overall survival (OS) in each arm
- Safety