JPRN-UMIN000006497招募中2 期
A phase II trial of sequential treatment from cisplatin-etoposide therapy (PE) to irinotecan hydrochloride + amrubicin hydrochloride therapy with concomitant use of G-CSF nartograstim in patients with extensive-stage small cell lung cancer or advanced large cell neuroendocrine carcinoma (LCNEC) - Investigational study on the efficacy and safety of sequential treatment from PE therapy to CPT + AMR combination therapy with concomitant use of NUP in patients with extensive small cell lung cancer or stage IIIB/IV large cell neuroendocrine carcinoma
Department of Respiratory Medicine Kitasato University School of Medicine0 个研究点目标入组 31 人开始时间: 2011年10月7日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 31
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) Superior vena cava syndrome 2) History of severe drug allergy 3) Large pleural effusion, ascites, and/or cardiac effusion 4) Clinically relevant infectious disease 5) Diarrhea (watery diarrhea) 6) Intestinal paralysis and/or ileus 7) Obvious interstitial pneumonia and/or pulmonary fibrosis based on chest X-ray 8) Brain metastasis with any symptoms; however, asymptomatic patients may be enrolled if symptoms are resolved after radiotherapy, not steroid therapy. 9) Simultaneously active double cancer*1 10) Uncontrollable diabetic disease 11) Clinically relevant cardiac diseases*2 12) Patients judged to be difficult to participate in the trial due to a clinically relevant neuropsychiatric disorder, etc. 13) Pregnant or lactating women, or those who may become pregnant or who have no intention of contraception 14) Patients whose participation in the trial was judged to be inappropriate due to safety reasons by investigators, etc. *1Double cancer comprises simultaneous double cancer and metachronous double cancer with a disease-free interval of 5 years or shorter. However, active double cancer does not include in-situ carcinoma or intramucosal carcinoma judged to be recovered by local treatment. *2These include congestive cardiac failure, symptomatic coronary artery disease, uncontrollable arrhythmia, and myocardial infarction occurring within preceding 6 months.
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