NCT00274872Unknown2 期
Phase II-III Study of an Optimized LV-5FU-Oxaliplatin Strategy in Metastatic Colorectal Cancer. Optimox2 Study. C02-2
GERCOR - Multidisciplinary Oncology Cooperative Group34 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2004年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 600
- 试验地点
- 34
- 主要终点
- Response as measured by RECIST criteria
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil, 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. It is not yet known which combination chemotherapy regimen is more effective in treating colorectal cancer.
PURPOSE: This randomized phase II/III trial is studying two combination chemotherapy regimens to compare how well they work in treating patients with metastatic colorectal cancer that cannot be removed by surgery.
详细描述
OBJECTIVES:
Primary
- Compare progression-free survival of patients with inoperable metastatic colorectal cancer treated with oxaliplatin, leucovorin calcium, and fluorouracil with vs without maintenance leucovorin calcium and fluorouracil.
- Demonstrate that time of disease control (TDC) can be increased by 15% at 9 months and that maintenance therapy can be avoided.
Secondary
- Compare the overall survival and response rate in patients treated with these regimens.
- Compare the salvage surgery rate in patients treated with these regimens.
- Compare the tolerability of these regimens in these patients.
- Compare the quality of life in patients treated with these regimens.
- Compare the duration of chemotherapy-free intervals in patients treated with these regimens.
- Compare the pharmacoeconomy and pharmacogenetics of these regimens in these patients.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically proven adenocarcinoma of the colon or rectum
- •Metastatic disease
- •No metastases involving only the bone
- •Inoperable disease (i.e., not suitable for complete surgical resection)
- •Measurable or evaluable disease
- •Measurable disease defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional CT scan OR ≥ 10 mm by spiral CT scan
- •No symptomatic ascites or pleural effusion that has not been evacuated
- •No CNS metastasis
- •PATIENT CHARACTERISTICS:
- •WHO OR ECOG performance status 0-2
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelets ≥ 100,000/mm^3
- •Creatinine < 3 times upper limit of normal (ULN)
- •Alkaline phosphatase < 5 times ULN
- •No peripheral neuropathy ≥ grade 1
- •No total or partial bowel obstruction
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No uncontrolled hypercalcemia
- •No other concurrent or prior malignancy, except adequately treated carcinoma in situ of the uterine cervix or basal or squamous cell carcinoma of the skin or cancer in complete remission for ≥ 5 years
- •No uncontrolled congestive heart failure
- •No angina pectoris
- •No hypertension
- •No arrhythmias
- •No history of significant neurologic or psychiatric disorders
- •No active infection
- •No other serious nonmalignant disease
- •PRIOR CONCURRENT THERAPY:
- •No prior chemotherapy and/or immunotherapy for metastatic disease
- •Prior adjuvant chemotherapy allowed provided progression-free interval after completion of adjuvant chemotherapy is > 6 months
- •No other concurrent anticancer treatment
- •No participation in another clinical trial with any investigational drug within 30 days prior to randomization
- •No other concurrent investigational treatment
- •No concurrent radiotherapy
- •No concurrent cold cap for prevention of alopecia or iced mouth rinses for prevention of stomatitis
排除标准
- 未提供
结局指标
主要结局
Response as measured by RECIST criteria
Overall survival
Toxicity
Time to disease control
Quality of life as assessed by EUROQOL- 5 Dimensional Instrument or Functional Assessment of Cancer Therapy-Neurotoxicity module version 4.0 at baseline and periodically during study treatment
Pharmaco-economic evaluation
次要结局
未报告次要终点
研究者
研究点 (34)
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