NCT00263055已完成4 期
Multicenter Asia Study in Adjuvant Treatment of Colon Cancer With OxaliplaTin/5FU-LV
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 试验地点
- 6
- 主要终点
- Occurrence of dose-limiting toxicity
研究概览
简要总结
Safety & tolerability of FOLFOX4 regimen in the adjuvant treatment of colon cancer in Asian patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Histologically proven stage Dukes " B2 " (stage II: T3-T4 N0 M0) and " C " (stage III: any T N1-2 M0) colon carcinoma. The inferior pole of the tumor must be above the peritoneal reflection (> 15 cm from the anal margin).
- •Patients must have undergone complete resection of the primary tumor without gross or microscopic evidence of residual disease
- •Patients must be entered in the study in order to start treatment within 7 weeks after surgery
- •Age 18-75 years old
- •Performance Status ≤ 2 (Karnofsky > or = 60%)
- •No previous chemotherapy, immunotherapy or radiotherapy
- •No biological major abnormalities :Absolute neutrophil count > 1.5 x 10^9/l,Platelets ≥ 100 x 10^9/l,Serum creatinine ≤ 1.25 times the upper limit of normal, total bilirubin, ASAT / ALAT < 2 times the upper limit of the normal range,carcinoembryonic antigen < 10 ng/ml.
- •Documentation of a negative pregnancy test must be available for premenopausal women with intact reproductive organs
- •Men and women who are fertile must use a medically acceptable contraceptive throughout the treatment period and for 3 months following cessation of treatment with oxaliplatin. Subjects must be made aware, before entering this trial of the risk of becoming pregnant or in fathering children
- •Signed informed consent obtained prior to study entry
- •Exclusion criteria
- •Pregnant or lactating women
- •Women of child bearing potential not using a contraceptive method
- •Previous cancer of the colon or rectum
- •Previous malignancies other than adequately treated in situ carcinoma of the uterine cervix or basal or squamous cell carcinoma of the skin, unless there has been a disease-free interval of at least 10 years
- •Participation in another clinical trial with any investigational drug within 30 days prior to randomization
- •Peripheral neuropathy (NCI CTC [National Cancer Institute Common Toxicity Criteria] > or = Grade I)
- •Uncontrolled congestive heart failure or angina pectoris, or hypertension or arrhythmia
- •History of significant neurologic or psychiatric disorders
- •Active infection
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
排除标准
- 未提供
结局指标
主要结局
Occurrence of dose-limiting toxicity
时间窗: from the inform consent signed up to the end of the study
次要结局
- Occurrence of one or more adverse event in a patient(From the Informed Consent Form (ICF) signature to the end of the study)
- Overall distribution of intensity of adverse events(from the inform consnet signed up to the end of the study)
- Occurrence of particular adverse events and their intensities(from the inform consent signed up to the end of the study)
- Percent of patients completing study treatment(from the inform consent signed up to the end of the study)
- Percent of patients with grade 1, 2 and 3 neuropathy(at 28 days, 6 months and 12 months after last chemotherapy administration.)
- Percent of intended dose delivered for 5-FU/LV and Oxaliplatin(from the informed consent signed up to the end of the study)
- Delays in scheduled dosing(During the study conduct)
- Dose intensity, as expressed as the amount of 5-FU/LV and Oxaliplatin administered divided by the duration of treatment(during the study conduct)
- •Survival Analysis •Laboratory assay and vital signs ECOG and KPS(during the study conduct)
- Long term toxicity(during the study conduct)
研究者
研究点 (6)
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