EUCTR2007-005639-26-ES进行中（未招募）不适用
A Multicenter, Double Blind, Placebo controlled, Randomized study of TroVax vs Placebo in the First Line treatment of Patients with Metastatic Colorectal Cancer receiving Standard of Care.-----------------------------------------------------------------------------------------------Estudio multicéntrico, doble ciego, controlado con placebo y aleatorizado de TroVax? frente a placebo en el tratamiento de primera línea de pacientes con cáncer colorrectal metastásico que reciben el tratamiento habitual. - FLAMENCO
Oxford BioMedica0 个研究点目标入组 1,300 人开始时间: 2008年2月5日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,300
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
- •- Patients with histology/cytology confirmed colorectal adenocarcinoma
- •- Metastatic colorectal cancer
- •- No prior palliative chemotherapy
- •- Patient's informed consent obtained, signed and dated.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •* Related to study methodology
- •- Age < 18 years old
- •- ECOG performance status > 2
- •- (Neo)Adjuvant chemotherapy if <6 months between end of chemotherapy and relapse.
- •- Prior Radiotherapy (< 6 weeks) or surgery (< 3 weeks) before randomization
- •- Patients with resectable liver or lung metastasis
- •- Known brain metastasis or leptomeningeal disease
- •- History of other neoplasms
- •- Life expectancy < 3 months
- •- Any contraindication to administer the chosen SOC
- •* Exclusion criteria related to Standard of Care
- •* Exclusion criteria related to TroVax
- •- Lymphocytes < 1 x 10e9/L
- •- Serious infection within 28 days prior to randomization
- •- History of hypersensitivity to vaccinia vaccination, egg protein or neomycin
- •- Known positive test to HIV or active and/or requiring treatment hepatitis B or C
- •- Active eczema with lesions on the skin
研究者
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