NCT00004150已完成3 期
Pan-European Trials in Adjuvant Colon Cancer (PETACC-2): Randomized Phase III Intergroup Trial of High-Dose Infusional 5-FU (+ or - Folinic Acid) Versus Standard Bolus 5-FU/Folinic Acid
Robert Roessle Klinik169 个研究点 分布在 6 个国家开始时间: 1999年3月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 试验地点
- 169
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which chemotherapy regimen is more effective for colon cancer.
PURPOSE: This randomized phase III trial is studying high-dose fluorouracil with or without leucovorin to see how well it works compared to standard-dose fluorouracil and leucovorin in treating patients who have undergone surgery for stage III colon cancer.
详细描述
OBJECTIVES:
- Compare recurrence-free survival and duration of survival in patients with stage III adenocarcinoma of the colon treated with adjuvant high-dose fluorouracil with or without leucovorin calcium versus standard fluorouracil with leucovorin calcium following curative radical resection.
- Compare the safety of these regimens in this patient population.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to regional lymph node involvement (N1 (1-3 pericolic lymph nodes) vs N2 (more than 3 pericolic lymph nodes) and participating center.
Patients are randomized to one of two treatment arms.
- Arm I: Patients receive leucovorin calcium IV followed by fluorouracil IV on days 1-5. Treatment repeats every 4 weeks for 6 courses.
- Arm II: Patients receive high-dose fluorouracil IV continuously over 48 hours weekly for 8 weeks. Treatment repeats every 8 weeks for 3 courses.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed stage III adenocarcinoma or mucinous adenocarcinoma of the colon
- •Must have had curative radical resection within 56 days prior to study
- •No local tumor therapy (i.e., polypectomy, local excision or limited intestinal resection)
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •WBC at least 3,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Hemoglobin greater than 10.0 g/dL
- •Bilirubin no greater than 2.0 mg/dL
- •Creatinine no greater than 1.5 mg/dL
- •Cardiovascular:
- •No severe coronary heart disease
- •No New York Heart Association class III or IV heart failure
- •No other malignancy within the past 10 years except adequately treated basal cell skin cancer or carcinoma in situ of the cervix
- •No uncontrolled infection
- •No other severe disease
- •No known allergy to leucovorin calcium
- •No known familial adenomatous polyposis, Crohn's disease, or ulcerative colitis
- •No hereditary syndrome (e.g., Gardner's syndrome, Turcot's syndrome, hereditary nonpolyposis colon cancer)
- •Not pregnant or nursing
- •Fertile patients must use effective contraception during and for 6 months after study participation
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •No prior chemotherapy for colon cancer
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •No prior radiotherapy for colon cancer
- •See Disease Characteristics
- •No other concurrent systemic anticancer therapy
排除标准
- 未提供
研究者
研究点 (169)
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