JPRN-jRCTs061180022进行中（未招募）2 期
A randomized phase II study to investigate the deepness of response of FOLFOXIRI plus cetuximab (Erbitux) versus FOLFOXIRI plus bevacizumab as the first-line therapy in metastatic colorectal cancer patients with RAS wild-type tumors: DEEPER
TSUJI Akihito0 个研究点目标入组 360 人开始时间: 2019年2月14日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 360
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •(1) Histologically confirmed colorectal cancer.
- •(2) RAS wild-type.
- •(3) Measurable leision by RECIST.(Ver.1.1)
- •(4) No past history of chemotherapy in the case of unresectable primary lesion/distant metastasis/lymph node metastasis.In the case of recurrence, no treatment for the first recurrence leision after operation.
- •(5) Age; more than 20 years old.
- •(6) ECOG Performance status 0-1.The case >=71 years is PS0.
排除标准
- •(1)Synchronous multiple malignancy or metachronous multiple malignancy within 5 years disease free interval. (2)Suspicious of Lynch syndrome
- •(3)Brain metastases.
- •(4)Infectious disease.
- •(5)Interstitial lung disease or pulmonary fibrosis.
- •(6)Comorbidity or history of serious heart failure.
- •(7)History of thromboembolic events.
- •(8)Cerebrovascular disease.
- •(9)History of hemoptysis/hematemesis.
- •(10)Uncontrolled hypertension.
- •(11)Sensory alteration or paresthesia interfering with function.
- •(12)Large quantity of pleural, abdominal or cardiac effusion.
- •(13)Severe comorbidity (renal failure, liver failure, hypertension, etc)
- •(14) Prior radiotherapy for primary and metastases leision.
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