JPRN-UMIN000004011已完成2 期
Multicenter Phase II sequential study of S-1/Oxaliplatin (SOX) and Bevacizumab as first line therapy followed by S-1/Irinotecan (IRIS) and Cetuximab as second line in patients with metastatic colorectal cancer. : A SOBIC study - SOBIC study
Hyogo Colorectal Cancer Study Group0 个研究点目标入组 52 人开始时间: 2010年8月20日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 52
研究概览
简要总结
The median second progression-free survival was 24.2 months (95% confidence interval [CI] 17.7 35.2). The response rate after first- and second-line chemotherapy was 46.7% and 20%, respectively. The median overall survival was 35.2 months (95% CI: 27.8 to not reached). The main grade 3,4 adverse events were sensory neuropathy (18%), fatigue (10%), and anorexia (8%). There were no treatment-related deaths among patients administered the first-line and second-line regimens.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 80years-old(—)
- 性别
- All
入选标准
- 未提供
排除标准
- •(1) History of the serious hypersensitivity for Fluorouracil, oxaliplatin or bevacizumab (2) Pregnant or lactating women or women of childbearing potential. (3) Severe infectious disease (4) Serious complication (e.g. interstitialpneumonia, or pulmonary fibrosis, kidney injury, hepatic failure, uncontrolled diabetes mellitus, uncontrolled hypertension) (5) Comorbidity or history of heart failure (6) Peptic ulcers (7) Severe dysesthesia or sensory abnormality with functional disorder (8) Severe diarrhea (9) Massive pleural effusion or ascites. (10) Obstruction or disorder on digestive tract due to peritoneal metastasis
研究者
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