JPRN-jRCTs031180216进行中（未招募）3 期
JCOG1205/1206: A Phase III Study Comparing Irinotecan and Cisplatin with Etoposide and Cisplatin for Adjuvant Chemotherapy of Completely Resected Pulmonary High-grade Neuroendocrine Carcinoma - HGNEC-EP/IP-P3
TSUBOI Masahiro0 个研究点目标入组 220 人开始时间: 2019年3月8日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 220
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
- >= 20age old 至 <= 74age old（—）
- 性别
- All
入选标准
- •1) Pathologically proven high-grade neuroendocrine carcinoma (small cell carcinoma including combined small cell carcinoma or large cell neuroendocrine carcinoma including combined large cell neuroendocrine carcinoma)
- •2) Pathological stage I-IIIA based on the TNM classification 2009
- •3) Pathologically proven either of R0, R1 (is), or R1 (cy+)
- •4) Aged 20 to 74 years old
- •5) ECOG performance status of 0 or 1
- •6) Lobectomy or more extended surgery was performed
- •7) ND 2a-1 or more extended lymph node dissection was performed.
- •8) Within 28 to 56 days after surgery
- •9) No distant metastases including brain metastasis
- •10) No prior chemotherapy or radiotherapy for any other cancers
- •11) Adequate organ functions
- •12) Without diarrhea and intestinal obstruction of grade 1 or greater based on CTCAE v4.0.
- •13) Written informed consent
排除标准
- •1) Synchronous or metachronous (within 5 years) malignancies except carcinoma in situ or intramucosal tumor curatively treated with local therapy
- •2) Active infection requiring systemic therapy
- •3) Body temperature >= 38 degrees Celsius
- •4) Pregnant or lactating women or women of childbearing potential
- •5) Psychiatric disease
- •6) Serious postoperative complications
- •7) Patients requiring systemic steroids medication
- •8) Poorly controlled diabetes mellitus or routine administration of insulin
- •9) Poorly controlled hypertension
- •10) Unstable angina within 3 weeks, or with a history of myocardial infarction within 6 months
- •11) Positive HBs antigen
- •12) Positive HIV antibody
- •13) Interstitial pneumonia, pulmonary fibrosis, or severe emphysema
研究者
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