EUCTR2005-000117-34-DK进行中（未招募）不适用
Combination of 5-Fluorouracil/Folinate/Oxaliplatin (Eloxatin®) (FLOX regimen) with Concomitant or Concomitant and Maintenance Administration of Cetuximab (Erbitux®), in First-Line Treatment of Metastatic Colorectal Cancer. - Nordic VII
The Nordic Colorectal Cancer Biomodulation Group0 个研究点目标入组 550 人开始时间: 2008年7月10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
- 550
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
- •Histology and staging disease:
- •Histologically proven adenocarcinoma of the colon or rectum;
- •At least one measurable metastatic disease ? uni-dimensionnally measurable
- •lesion according to RECIST criteria;
- •If only one metastatic lesion and no S-CEA elevation, histology is mandatory;
- •General conditions:
- •Age >18 and < 75 years;
- •WHO performance status < 2; life expectancy of more than 3 months;
- •Adequate haematological function: (Hb > 10g/dl, ANC >1.5 x 109/L, platelets >100
- •Adequate renal and hepatic functions: total bilirubin <1.5 upper normal limits (unl),
- •creatinine <1.25 × unl, ALAT < 5 x unl in case of liver involvement;
- •Written informed consent prior to randomization must be obtained and ocumented
- •according to the local regulatory requirements.
- •Prior therapy:
- •No prior chemotherapy for advanced/metastatic disease;
- •Adjuvant chemotherapy must have ended > 6 months before inclusion;
- •No previous oxaliplatin
- •Prior or current history:
- •No current indication for resection with a curativw intent;
- •No evidence of CNS metastasis;
- •No current infection, unresolved bowel obstruction or subobstruction, uncontrolled
- •Crohn's disease or ulcerative colitis;
- •No current history of chronic diarrhoea;
- •No peripheral neurophathy;
- •No other serious illness or medical conditions (including contraindication to 5 FU
- •eg: angor, myocardial infarction within 6 months, contraindications to monoclonal
- •antibodies);
- •No past or concurrent history of malignant neoplasm other than colorectal
- •adenocarcinoma within the past five years, except curatively treated non
- •melanoma skin cancer or in situ carcinoma of the cervix;
- •Concomitant treatments:
- •No concomitant (or within 4 weeks before randomization) administration of any
- •other experimental drug under investigation;
- •No concurrent treatment with any other anti-cancer therapy;
- •Not pregnant or breast feeding
- •Fertile patients must use adequate contraceptives
- •Not include patients clearly intending to withdraw from the study if not randomised
- •in the willing arm or patients who cannot be
- •regularly followed up for psychological, social, familial or geographic reasons.
- •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
- •See inclusion criteria
研究者
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