NCT00091312Unknown3 期
Randomized Phase III Intergroup Trial in Resected Stage 2 (Dukes B) Colon Cancer: 6-Month Infusional 5FU-CPT11 (+/- Folinic Acid) Versus Observation - Determination of Biologic Predictive and Response Factors
Federation Francophone de Cancerologie Digestive17 个研究点 分布在 6 个国家目标入组 1,976 人开始时间: 2004年6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
- 1,976
- 试验地点
- 17
- 主要终点
- Disease-free survival at 5 years
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as irinotecan, leucovorin, and fluorouracil, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them after surgery may kill any remaining tumor cells. It is not yet known whether combination chemotherapy is more effective than observation alone in treating patients who have undergone surgery for colon cancer.
PURPOSE: This randomized phase III trial is studying irinotecan and fluorouracil with or without leucovorin to see how well they work compared to observation alone in treating patients who have undergone surgery for stage II colon cancer.
详细描述
OBJECTIVES:
Primary
- Compare 5-year disease-free survival in patients with resected stage II adenocarcinoma of the colon treated with adjuvant chemotherapy comprising fluorouracil and irinotecan with or without leucovorin calcium vs no adjuvant therapy.
Secondary
- Compare 8-year overall survival in patients treated with these regimens.
- Compare tolerability of these regimens in these patients.
- Correlate clinical, histological, and biological prognostic factors with outcome in patients treated with these regimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed adenocarcinoma of the colon
- •Stage II disease (pT3, N0 or pT4, N0)
- •Penetration of the subserosa or serosa
- •No lymph node metastases
- •At least 12 lymph nodes analyzed
- •More than 1 synchronous primary colon tumor allowed
- •Staging determined for the more advanced tumor
- •Curative radical resection within the past 2-8 weeks required
- •Proximal, distal, and radical margins must be free of tumor (R0 resection)
- •No rectal tumors
- •Gross distal margin of the primary tumor must lie above the peritoneal reflection
- •No known familial adenomatous polyposis
- •No hereditary nonpolyposis colorectal cancer
- •No distant metastases
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Granulocyte count ≥ 2,000/mm^3
- •Platelet count ≥ 100,000mm^3
- •Hemoglobin ≥ 10 g/dL
- •Bilirubin < 1.25 times upper limit of normal (ULN)
- •No known Gilbert's syndrome
- •Creatinine < 1.25 times ULN
- •Cardiovascular
- •No severe or uncontrolled coronary disease
- •No severe heart failure
- •No uncontrolled arterial hypertension
- •No myocardial infarction within the past year
- •No cerebral vascular accident within the past year
- •Cardiac arrhythmia allowed provided patient is on proper anticoagulation therapy* NOTE: *Aspirin is not considered proper anticoagulation
- •Gastrointestinal
- •No Gardner's syndrome
- •No Turcot's syndrome
- •No Crohn's disease
- •No ulcerative colitis
- •No other prior malignancy except adequately treated basal cell skin cancer or carcinoma in situ of the cervix
- •No other serious disease
- •No contraindication to any study drugs
- •No known allergy to leucovorin calcium
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for up to 6 months after study treatment
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •No prior chemotherapy
- 另有 7 项未显示
排除标准
- 未提供
结局指标
主要结局
Disease-free survival at 5 years
次要结局
- Overall survival at 8 years
- Tolerability
- Correlation of clinical, histological, and biological prognostic factors with outcome
研究者
研究点 (17)
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