JPRN-UMIN000011486已完成2 期
Randomized Phase II study of SOX vs mFOLFOX6 as neoadjuvant chemotherapy in patients with resectable rectal cancer (KSCC1301) - Randomized Phase II study of SOX vs mFOLFOX6 as neoadjuvant chemotherapy in patients with resectable rectal cancer (KSCC1301)
Kyushu Study group of Clinical Cancer(KSCC)0 个研究点目标入组 110 人开始时间: 2013年8月14日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 110
研究概览
简要总结
ASCO 2017(2017/6/2~6CHICAGO,ILLINOIS in USA) A Randomized PhaseII Study Evaluating Efficacy and Safety of SOX versus mFOLFOX6 as Neoadjuvant Chemotherapy for Patients with Resectable Rectal cancer(KSCC1301)
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1) History of serious drug hypersensitivity or a history of drug allergy 2) Pregnant or lactating woman and man who hope for Partner's pregnant 3) Active infection(over 38 degree) 4) Blood transfusion within 14 days before registration 5) Serious complication ( ex. interstitial pneumonitis, pulmonary fibrosis, renal failure, liver failure, serious diabetes, serious hypertension) 6) Clinically significant abnormal electrocardiogram or heart disease 7) Serious diarrhea 8) Pleural effusion, peritoneal fluid that needs treatment 9) Previous history of serious lung disorder ( ex. interstitial lung disease or fibrosis, serious emphysema ) 10) Hemorrhagic diathesis, coagulation disorder 11) Active double cancer (synchronous double cancer or asynchronous double cancer with disease-free duration of 5 years or less). 12) Patients who need flucytosine, phenytoin or warfarin potassium. 13) Requiring steroid drug 14) Patients with contraindication to therapy 15) History of allergy to contrast material 16) Serious stricture (exclude the patients who are put in stoma) 17) Positive for HBs antigen and HCV antibody 18) Not appropriate for the study at the physician's assessment
研究者
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