JPRN-UMIN000007242已完成2 期
A Phase II Clinical Trial of CBDCA and TS-1 concurrent chemotherapy followed by TS-1 Maintenance Therapy for Advanced and Recurrent Squamous Cell Lung Cancer: SMILE Trial - A Phase II Clinical Trial of CBDCA and TS-1 concurrent chemotherapy followed by TS-1 Maintenance Therapy for Advanced and Recurrent Squamous Cell Lung Cancer: SMILE Trial
ational Hospital Organization Shikoku Cancer Center0 个研究点目标入组 30 人开始时间: 2012年2月7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
- 30
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) Any previous first line treatment with radiotherapy (including chemo radiotherapy) 2) Administration contraindication to Carboplatin and S-1. 3) Severe complications, such as cardiac failure, renal failure, hepatic failure, hemorrhagic gastric or duodenal ulcer, ileus, and uncontrollable or insulin-treated diabetic. 4) Severe drug allergies or history of drug hypersensitivity 5) Symptomatic or apparent interstitial pneumonia/lung fibrosis on CT scan or X-ray image findings (Included positive suspicion or history of them). 6) Severe watery diarrhea 7) With active infection. Fever higher than 38 degrees celsius. 8) HBsAg positive patients 9) The brain metastases which require emergent treatment. 10) Patients with ascites, pleural or pericardial effusion requiring drainage. 11) Patients undergoing UFT or TS-1 adjuvant therapy. The case postoperative recurrence within 6 months after adjuvant therapy. 12) Active concomitant malignancy with disease-free duration to be within 3 years. 13) Required to continue Flucytosine (5- FC), phenytoin and warfarinpotassium. 14) Pregnant, lactating or women of child-bearing potential. Men who want get partner pregnant. 15) The case that is judged to be inadequacy for this study
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