JPRN-UMIN000002845已完成1 期
Phase I Trial of S-1 and Weekly Oxaliplatin in Combination with Radiotherapy for Neoadjuvant Therapy of Locally Advanced Rectum Cancer - SOX-RT(P-I)
ational cancer center hosital0 个研究点目标入组 12 人开始时间: 2009年12月4日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 75years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1. Suspected metastasis of external iliac lymph nodes, para-aortic lymph nodes, or inguinal lymph nodes by pelvic MRI. 2. Prior or synchronous invasive malignancy (expect carcinoma in situ or superficial carcinoma which is able to eradicate by local therapy) unless disease free for a minimum of 5 years 3. Evidence of active bacterial or fungal infection (existing fever above 38 degrees centigrade due to infection) 4. Previous history of severe drug-induced allergy 5. Need to treatment with flucytosine, atazanavir sulfate, or warfalin 6. Need systemic administration of corticosteroids 7. Evidence of positive hepatitis B virus surface antigen 8. Evidence of severe watery diarrhea 9. Evidence of uncontrolled diabetic mellitus 10. Evidence of uncontrolled hypertension 11. Need to intervention for heart disease according to the findings of electrocardiogram within the last 28 days 12. Myocardial infarction or unstable angina pectoris within the last 12 months 13. Major surgery within 4 weeks of study enrollment (other than diverting colostomy) 14. Severe comorbidity (ie, bowel paralysis, bowel obstruction, interstitial pneumotitis, pulmonary fibrosis, advanced emphysema, heart disease which is difficult to manage, renal failure, hepatic failure) 15. Pregnant or lactating and woman with childbearing potential who lacked effective contraception 16. Evidence of psychiatric disability interfering with enrollment to clinical trial 17.Patients judged inappropriate for this study by the physicians
研究者
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