NCT00182715Unknown3 期
A Three-Arm Randomised Controlled Trial Comparing Either Continuous Chemotherapy Plus Cetuximab or Intermittent Chemotherapy With Standard Continuous Palliative Combination Chemotherapy With Oxaliplatin and a Fluoropyrimidine in First Line Treatment of Metastatic Colorectal Cancer (COIN)
Velindre NHS Trust160 个研究点 分布在 2 个国家目标入组 2,421 人开始时间: 2005年3月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 2,421
- 试验地点
- 160
- 主要终点
- Overall survival at 2 years
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether combination chemotherapy and cetuximab are more effective than combination chemotherapy alone in treating colorectal cancer.
PURPOSE: This randomized phase III trial is studying combination chemotherapy and cetuximab to see how well they work compared to combination chemotherapy alone as first-line therapy in treating patients with metastatic colorectal cancer.
详细描述
OBJECTIVES:
Primary
- Compare the overall survival of patients with metastatic colorectal adenocarcinoma treated with continuous combination chemotherapy comprising oxaliplatin, leucovorin calcium, and fluorouracil (OxMdG) or oxaliplatin and capecitabine (XELOX) with vs without cetuximab vs intermittent combination chemotherapy with OxMdG or XELOX as first-line therapy.
Secondary
- Compare time of disease control and progression- and failure-free survival of patients treated with these regimens.
- Compare response in patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
- Compare the cost effectiveness of these regimens in these patients.
- Compare the quality of life of patients treated with these regimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of colorectal adenocarcinoma, defined by 1 of the following:
- •Histologically confirmed primary adenocarcinoma of the colon or rectum with clinical or radiological evidence of advanced and/or metastatic disease
- •Histologically or cytologically confirmed metastatic adenocarcinoma with clinical or radiological evidence of primary colorectal tumor
- •Unidimensionally measurable disease
- •Inoperable metastatic or locoregional disease
- •Ineligible for hepatic resection after first-line combination chemotherapy
- •No brain metastases
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Bilirubin ≤ 1.25 times upper limit of normal (ULN)
- •Alkaline phosphatase ≤ 5 times ULN
- •AST or ALT ≤ 2.5 times ULN
- •Creatinine clearance or glomerular filtration rate ≥ 50 mL/min
- •Cardiovascular
- •No poorly controlled angina
- •No myocardial infarction within the past 3 months
- •Not pregnant
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Must be considered fit to undergo combination chemotherapy
- •No psychiatric or neurological condition that would preclude study compliance or giving informed consent
- •No partial or complete bowel obstruction
- •No other malignant disease that would preclude study treatment
- •No preexisting neuropathy > grade 1
- •No known hypersensitivity reaction to any of the components of study drugs
- •No known DPD deficiency or personal or family history suggestiv of DPD deficiency
- •No other severe uncontrolled medical illness that would preclude study treatment
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •No prior systemic palliative chemotherapy for metastatic disease
- •No prior oxaliplatin
- •More than 1 month since prior adjuvant fluorouracil (5-FU) (with or without leucovorin calcium), capecitabine, or irinotecan
- •More than 1 month since prior rectal chemoradiotherapy with 5-FU (with or without leucovorin calcium) or capecitabine
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •See Chemotherapy
- •Not specified
- •No concurrent brivudine or sorivudine (for patients receiving capecitabine on study)
排除标准
- 未提供
结局指标
主要结局
Overall survival at 2 years
次要结局
- Response by RECIST criteria at 12 and 24 weeks
- Toxicity by NCI Common Toxicity Criteria version 3 throughout treatment and at follow-up
- Time of disease control at 2 years
- Progression-free survival at 2 years
- Failure-free survival at 2 years
研究者
研究点 (160)
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