JPRN-jRCTs071180083进行中（未招募）1 期
Feasibility study of adjuvant chemotherapy with cisplatin(CDDP) and TS-1 in followed by alternate-day treatment with TS-1 in patients with completely resected pathological II-IIIA non small cell lung cancer - None
Suzuki Makoto0 个研究点目标入组 58 人开始时间: 2019年3月29日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 58
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 < 80age old（—）
- 性别
- All
入选标准
- •1) Pathologically confirmed diagnosis of NSCLC.
- •2) Non-small cell lung cancer with stage II-IIIA
- •3) Completely resected
- •4) Oral intake
- •5) LN dissection more than ND2a-1
- •6) Neither previous chemotherapy nor radiotherapy before operation
- •7) Performance Status (ECOG) 0-2
- •8) Aged 20-75 years old
- •9)Have adequate organ function within 14 days before study entry
- •a.Leukocyte count 3,000/mm3 or over
- •b.Granulocyte count 1,500/mm3 or over
- •c.Platelet count 100,000/mm3 or over
- •d.Hb 9.0 g/dl or over
- •e.AST(GOT) 2.5 x the Upper Limits of Normal(ULN) or under
- •f.ALT(GPT) 2.5 x the Upper Limits of Normal (ULN) or under
- •g.Total bilirubin 1.5 mg/dL or under
- •h.Serum creatinine 1.5 mg/dl or under
- •i. creatinine clearance 50 mL / min or over
- •j.PaO2 60torr or over or SpO2 90% or over
- •10) Written informed consent to participate.
- •11) Possible to receive chemotherapy within 8 week after surgery
排除标准
- •1)Anamnesis of hypersensitivity to drugs
- •2)Massive pleural or pericardial effusion
- •3) With active double cancer
- •4)Severe complication (ileus , interstitial pneumonia , interstitial pneumonia , pulmonary fibrosis, uncontrolled diabetes , heart failure , renal failure, hepatic failure, and so on)
- •5) With active infections
- •6) With a difficult bowel movement
- •7) Pleural effusion, cardiac effusion, or cardiac effusion necessitating treatment.
- •8) Pregnancy or lactating patients
- •9) Uncontrolled psychiatric disease
- •10)With poor-controlled diabetes mellitus
- •11) Concurrent steroid therapy
- •12) With HBs or HCV
- •13) With HIV
- •14) Physician judged improper to entry this trial
研究者
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