EUCTR2007-005639-26-DE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 Chemo-based Therapy. - FLAMENCO
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,312
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 (neo)adjuvant chemotherapy and relapse
- •- Less than 6 weeks elapsed from prior radiotherapy and less than 3 weeks from surgery to time to randomization.
- •- Treatment with an investigational agent within 4 weeks (6 weeks for immuno-therapy) of study enrollment.
- •- Patients with resectable liver or lung metastasis (study treatment should not be administered with neo-adjuvant intent in case of resectable liver or lung metastases or with adjuvant intent after surgery of liver or lung metastases).
- •- Known brain metastasis or leptomeningeal disease
- •- History of other neoplasms. Patients with a prior history of either non-metastatic nonmelanoma skin cancers, or carcinoma in situ of the cervix, or other cancer cured by surgery, or small field radiation or chemotherapy = 5 years prior to randomization are eligible.
- •- Life expectancy < 3 months
- •*Related to chemo-based therapy (biological functions within 8 days before first cycle: repeat in-range results within the screening period may replace previous out of range results in applying these exclusion criteria)
- •- Absolute neutrophil count (ANC) < 1.5 x 10e9/L, hemoglobin < 8.5 g/dL, platelet < 75 x 10e9/L.
- •- Bilirubin = 1.5 x ULN, AST/ALT or akaline phosphatase (AP) = 3.0 x ULN, or in case of liver involvement AST/ALT or AP = 5 x ULN.
- •- Creatinine > 1.0 x ULN, except in case of creatinine > 1.0 x ULN and = 1.5 x ULN if calculated creatinine clearance = 60 mL/min.
- •- Any other active illness such as uncontrolled cardiac disease or hypertension, uncontrolled diabetes that would preclude safe administration of study therapy at the time of randomization. Any of the following events within 6 months prior to randomization: myocardial infarction, severe/unstable angina, coronary/ peripheral artery bypass graft surgery, clinically symptomatic and uncontrolled cardiovascular disease, or clinically significant arrhythmias (grade 3-4).
- •* Related to TroVax
- •- Lymphocytes < 1 x 10e9/L
- •- Serious infection within 28 days prior to randomization
- •- History of hypersensitivity to vaccinia vaccination
- •- Known hypersensitivity to egg protein or neomycin
- •- Known positive test to HIV or any congenital or acquired immune deficiency, or active and/or requiring treatment hepatitis B or C.
- •- Active eczema with lesions on the skin
- •- Prior history of organ transplantation.
研究者
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