JPRN-UMIN000007986已完成2 期
A Phase II study of Pemetrexed plus split Cisplatin followed by maintenance Pemetrexed in previously untreated patients with stage III/IV or recurrent post-operative non-small-cell with non-squamous lung cancer. OSAKA-LCSG1103 - A Phase II study of Pemetrexed plus split Cisplatin followed by maintenance Pemetrexed in previously untreated patients with stage III/IV or recurrent post-operative non-small-cell with non-squamous lung cancer. OSAKA-LCSG1103
Department of respiratory medicine,Osala university Hospital.0 个研究点目标入组 53 人开始时间: 2012年5月18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
- 53
研究概览
简要总结
Thirty-eight (71.7%) patients completed induction therapy, while 35 (66.0%) received maintenance therapy. The 1-year survival rate was 67.7%. The median PFS and OS were 5.3 and 18.6 months, respectively. The response rate and disease control rate (DCR) during the induction phase were 37.7 and 86.8%, respectively. Eight patients (15.1%) discontinued the therapy due to adverse events (AEs) during the induction phase, but both hematological and non-hematological AEs were infrequent.
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)Patients have diagnosed squamous cell carcinoma 2)Interstitial pneumonia or pulmonary fibrosis detectable on Chest X-ray 3) Patiens has pleural effusion, pericardial effusion and ascites to need treatment for 4) Patients unable to administer folic acid and vitamin B12, or not 5) Severe renal function disorder 6) Pregnancy, breast feeding and suspected pregnancy 7) SVC syndrome 8) Active double cancer 9) Uncontrollable diabetes mellitus and hypertenson 10) Diagnosed as liver cirrhosis by image findings or clinical laboratory 11) History of severe heart disease (uncontrollable arrythmia, uncontrollable angina pectoris, congestive heart failue, etc within 6 months) 12) Pregnancy, breast feeding and suspected pregnancy 13) Grave drug allergic reaction 14) Acute inflammatory disease 15) An agreement is not obtained for support therapy such as transfusion etc 16) Having the bleeding tendency which is clear in clinic 17) Patients whose participation in the trial is judged to be inappropriate by the attendeing doctor
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