NCT00003063Unknown3 期
Adjuvant Chemoimmunotherapy for Colorectal Cancer
European Institute of Oncology168 个研究点 分布在 2 个国家目标入组 1,050 人开始时间: 1991年11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
- 1,050
- 试验地点
- 168
研究概览
简要总结
RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining chemotherapy with biological therapy may kill more tumor cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of treatment using levamisole with treatment using interferon alfa and combination chemotherapy consisting of fluorouracil and leucovorin in patients with stage II or stage III colorectal cancer.
详细描述
OBJECTIVES:
- Assess the efficacy of the addition of levamisole or alfa interferon to fluorouracil and leucovorin calcium (folinic acid) as an adjuvant treatment of intraperitoneal colorectal cancer.
OUTLINE: This is a three arm study. Patients are randomized to receive either levamisole, alfa interferon, or no treatment.
- Arm I: Patients receive levamisole PO for 3 days every 2 weeks for 6 months before and after surgery. Fluorouracil IV bolus and leucovorin calcium (folinic acid) IV over 1 hour are administered on days 1-5 every 4 weeks for 6 cycles after surgery.
- Arm II: Patients receive alfa interferon-2a SC on 3 alternate days for a week before surgery and for 6 months after surgery. Fluorouracil IV bolus and folinic acid IV over 1 hour are administered on days 1-5 every 4 weeks for 6 cycles after surgery.
- Arm III: Patients undergo surgery followed by fluorouracil IV bolus and folinic acid IV over 1 hour on days 1-5 every 4 weeks for 6 cycles.
Patients are followed every 3 months for 2 years, then every 6 months.
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
- — 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed stage T3-T4 N0 or T1-T4 N1-3 colorectal cancer
- •No evidence of residual disease after surgery
- •Tumor located above peritoneal reflection
- •No distant metastases
- •PATIENT CHARACTERISTICS:
- •75 and under
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •WBC at least 3500/mm3
- •Platelet count at least 100,000/mm3
- •Bilirubin no greater than 2.0 mg/dL
- •SGPT less than 2 times upper limit of normal
- •Creatinine no greater than 2.0 mg/dL
- •Cardiovascular:
- •No serious cardiac ischemia
- •Adequate metabolic functions
- •No prior neoplasm
- •No prior/concurrent illness
- •No insulin-dependent diabetes
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No prior immunotherapy for the current cancer
- •Chemotherapy
- •No prior chemotherapy for the current cancer
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •No prior radiotherapy for the current cancer
- •Not specified
排除标准
- 未提供
研究者
研究点 (168)
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