EUCTR2018-003778-29-IT进行中（未招募）1 期
Phase II study on the use of the FOLFIRI + Cetuximab association in the first-line treatment of patients with advanced colorectal carcinoma with wild type RAS and FcYRIIIA-V / V - CIFRA
Istituto Nazionale Tumori G. Pascale0 个研究点目标入组 34 人开始时间: 2019年1月14日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 34
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Cytological or histological diagnosis of colorectal adenocarcinoma
- •wild-type RAS
- •Fc?RIIIa-158V / V genotype
- •Negative pregnancy test where applicable
- •Age <75 years
- •At least 1 lesion measurable according to the RECIST criteria v1.1
- •ECOG Performance Status 0 or 1
- •Life expectancy> 3 months
- •Written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 14
排除标准
- •Previous systemic anti-tumor treatment; allowed treatment with Capecitabine or fluorouraciol and radiotherapy in the neoadjuvant setting of rectal tumors with therapy terminated for at least 6 months.
- •Presence of primary non-treated stenosing colorectal neoplasm with endoprosthesis positioning
- •Neutrophils <2000 / mm³ or platelets <100,000 / mm³ or hemoglobin <9 g / dl
- •Creatinineemia> 1.5 times the maximum normal value
- •GOT and / or GPT> 5 times the maximum normal value and / or bilirubinemia> 3 times the maximum normal value
- •Previous malignant neoplasm (excluding basal or spinocellular cutaneous carcinoma or in situ carcinoma of the uterine cervix)
- •Infection in active or uncontrolled phase
- •Other concomitant disorders that are decompensated or uncontrolled or that contraindicate the study drugs at the judgment of the clinician
- •Presence of brain metastases
- •Refusal or inability to provide informed consent
- •Impossibility to guarantee follow-up
研究者
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