JPRN-UMIN000012237已完成未知
Additional biomarker study of Randomized Phase III Study of Pemetrexed + Cisplatin and Vinorelbine + Cisplatin for Completely Resected Non-squamous Non-Small Cell Lung Cancer - Additional biomarker study of Randomized Phase III Study of Pemetrexed + Cisplatin and Vinorelbine + Cisplatin for Completely Resected Non-squamous Non-Small Cell Lung Cancer
Kinki University Faculty of Medicine0 个研究点目标入组 389 人开始时间: 2013年11月8日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 389
研究概览
简要总结
The study demonstrated the significance of tumor mutation burden as a biomarker for predicting the recurrence-free survival of pemetrexed/cisplatin in stage II-IIIA non-squamous non-small cell lung cancer patients.
研究设计
- 研究类型
- Observational
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) Have active double cancer (synchronous double cancer and metachronous double cancer within a 5-year disease-free interval are defined as active double cancer; in situ uterocervical carcinoma judged to be curable by topical therapy, gastric/colorectal cancer resectable by endoscopy, and topically resectable active skin diseases, except malignant melanoma, are not included in active double cancer); however, a patient is eligible even if double primary NSCLC is observed in the resected lung. 2) Previously treated with cisplatin, pemetrexed or vinorelbine 3) Administration of folic acid or Vitamin B12 is not possible. 4) Serious post-operative complications (post-operative infections, suture failures, etc.) 5) Interstitial shadow considered to be clearly indicative of interstitial pneumonia on chest CT 6) Active infection 7) Requirement of continuous systemic administration (oral or intravenous) of steroid at a dose > 10 mg/day in the case of prednisolone, and the current use of an immunosuppressant; however, patients currently treated with oral steroid at a dose of 10 mg/day in case of prednisolone can be enrolled in the study. 8) Women who are currently pregnant or will not be compliant with a medically approved contraceptive regimen during and for 6 months after the treatment period and lactating women. Men who will not be compliant with a contraceptive regimen during and for 6 months after the treatment period. 9) History of serious drug hypersensitivity 10) Other serious complications 11) Others judged by the investigator to be unsuitable for the study
研究者
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