NCT00506571Unknown2 期
Phase II Study of S-1 Combined With Irinotecan and Oxaliplatin in Patients With Previously Untreated Metastatic Colorectal Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Maximal overall response rate
研究概览
简要总结
Patients will be treated with irinotecan (150 mg/m2) followed by oxaliplatin (85 mg/m2) on day 1 and S-1 (80 mg/m2/day) from day 1 to 14 every 3 weeks. Patients will receive up to a planned treatment of maximum 12 cycles of chemotherapy. Response assessment will be performed every 2 cycles of chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed unresectable or metastatic colorectal cancer, not amenable to surgery or radiation treatment for curative intent
- •At least one unidimensional measurable lesion
- •ECOG performance status 0-
- •No prior chemotherapy in metastatic settings, but adjuvant or neo-adjuvant treatment for non-metastatic (M0) disease is allowed if completed at least 6 months prior to initiation of study treatment
- •Adequate major organ functions
- •Give written informed consent
排除标准
- •Prior systemic chemotherapy for metastatic disease
- •Prior treatment with oxaliplatin or irinotecan
- •Prior radiotherapy is permitted if it was not administered to target lesions selected for this study and provided it has been completed at least 4 weeks before registration
- •Prior surgical treatment of stage IV disease is permitted
- •CNS metastases
- •Prior history of peripheral neuropathy ≥ NCI CTC grade 1
- •Uncontrolled or severe cardiovascular disease
- •Serious concurrent infection or nonmalignant illness
- •Other malignancy within the past 3 years except cured non-melanomatous skin cancer or carcinoma in situ of the cervix
- •Organ allografts requiring immunosuppressive therapy
- •Psychiatric disorder or uncontrolled seizure that would preclude compliance
- •Pregnant, nursing women or patients with reproductive potential without contraception
- •Patients receiving a concomitant treatment with drugs interacting with S-1 such as flucytosine, phenytoin, or warfarin et al.
- •Prior unanticipated severe reaction to fluoropyrimidine therapy, or known dihydropyrimidine dehydrogenase (DPD) deficiency
- •Known hypersensitivity to platinum compounds or any of the components of the study medications
- •Major surgery within 3 weeks prior to study treatment starts, or lack of complete recovery from the effects of major surgery
- •Received any investigational drug or agent/procedure, i.e. participation in another trial within 4 weeks before beginning treatment with study drug
结局指标
主要结局
Maximal overall response rate
时间窗: During chemotherapy
次要结局
- Progression-free survival, Overall survival, Toxicity assessment, & Pharmacokinetic characteristics and association with genetic polymorphism
研究者
研究点 (2)
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