5-Fluorouracil/Folinate/Oxaliplatin (Eloxatin) (FLOX Regimen), Given Continuously or Intermittently, in Combination With Cetuximab (Erbitux), in First-line Treatment of Metastatic Colorectal Cancer. A Phase III Multicenter Trial.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 571
- 试验地点
- 1
- 主要终点
- To compare efficacy, as measured by time to disease progression, of treatment with cetuximab in combination with the FLOX regimen compared to FLOX alone, in first- line treatment of patients with metastatic cororectal cancer
研究概览
简要总结
The main objective of this trial is to explore the effect of combining an established chemotherapy regimen (FLOX), based on 5-fluorouracil, folinic acid, and oxaliplatin (Eloxatin®), with the EGF receptor antibody cetuximab (Erbitux®) in first-line treatment of metastatic colorectal cancer. The trial will investigate two regimens of FLOX plus cetuximab, in which FLOX is given continuously or intermittently, compared to standard FLOX without cetuximab.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histology and staging disease:
- •Histological proven adenocarcinoma of the colon or rectum;
- •At least one measurable metastatic disease
- •If only one metastatic lesion and no S-CEA elevation, histology is mandatory;
- •Availability of tumour sample for EGFR assessment.
- •General conditions:
- •Age >18 and < 75 years;
- •WHO performance status: life expectancy of more than 3 months;
- •Adequate haematological function
- •Adequate renal and hepatic functions
- •Written informed consent
排除标准
- •Prior therapy:
- •No prior chemotherapy for advanced/metastatic disease;
- •No adjuvant chemotherapy the last 6 months before inclusion;
- •No previous oxaliplatin;
- •Prior or current history:
- •No current indication for resection with a curative 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 neuropathy;
- •No other serious illness or medical conditions (including contraindication to 5 FU e.g.: 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 randomisation) administration of any other experimental drug under investigation;
- •No concurrent treatment with any other anti-cancer therapy;
- •Not pregnant, no 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, familiar or geographic reasons.
研究组 & 干预措施
A
FLOX: 5-fluorouracil/folinic acid/oxaliplatin; Nordic Regimen; given continuosly
干预措施: FLOX (5-fluorouracil/folinic acid/oxaliplatin) (Drug)
B
FLOX: 5-fluorouracil/folinic acid/oxaliplatin and cetuximab
干预措施: FLOX (5-fluorouracil/folinic acid/oxaliplatin) and Cetuximab (Drug)
C
FLOX given intermittently and maintenance cetuximab
干预措施: FLOX (5-fluorouracil and folinic acid and oxaliplatin) intermittently and maintenance cetuximab (Drug)
结局指标
主要结局
To compare efficacy, as measured by time to disease progression, of treatment with cetuximab in combination with the FLOX regimen compared to FLOX alone, in first- line treatment of patients with metastatic cororectal cancer
时间窗: Every 4th cycle
次要结局
- To measure response rates, response duration, secondary surgical curative resection frequency, safety profile, overall survival and quality of life in the treatment groups.(Every 2nd week (safety profile))