JPRN-jRCTs071180010进行中（未招募）2 期
A randomized phase 2 study of TS-1 versus CDDP+VNR for adjuvant therapy in patients with non-small cell lung cancer - LOGIK1702
Matsumoto Keitaro0 个研究点目标入组 110 人开始时间: 2018年12月17日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 110
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 < 75age old（—）
- 性别
- All
入选标准
- •1) Patients providing the written informed consent.
- •2) Patients with non-small-cell lung cancer histopathologically confirmed (except neuroendocrine carcinoma, mucoepidermoid carcinoma, adenoid cystic carcinoma).
- •3) Patients with total resection in pathological clinical stage II - IIIA which more than one lobe excision was carried out.
- •4) Patients with lymphadenectomy more than ND2a-1 or selective lymphadenectomy.
- •The selection method of the mediastinal lymph node should be dissected obeys the following criteria.
- •Right upper lobe lung cancer (LC) No. 2R, 4R
- •Left upper lobe segmentum superius LC No. 4L-6
- •Right middle lobe LC No. 2R, 4R, 7
- •Left upper lobe lingual LCNo. 4L-7
- •Right lower lobe LC No. 7-9
- •Left lower lobe LC No. 7-9
- •5) Patients without pre-treatment (radiation, chemotherapy) other than surgical treatment.
- •6) Patients who passed more than 28 days and less than 56days after the operation at the enrollment (it is eligible on the same day 4 weeks and 8 weeks before the enrolment day).
- •7) Patient is at least 20 years and less than 75 years of age (at enrollment date).
- •8) Patients capable of treatment with oral medicine.
- •9) Performance status (ECOG): 0-1
- •10) Patients having sufficient bone marrow, liver and renal function tolerable to chemotherapy (however, the following clinical laboratory test should be confirmed by the data within 14 days prior to enrollment).
- •White blood cell count 3,000-12,000/mm3
- •Platelet count >= 100,000/mm3
- •Haemoglobin >= 9.0g/dL
- •Total bilirubin <= 1.5mg/dL
- •AST, ALT <=100 IU/ml
- •BUN <= 25mg/dL
- •SpO2 >=90% or PaO2 >= 70 mmHg
- •Creatinine :Facility standard value or Creatinine clearance >= 60 ml/min
- •(actual value or converted value from serum creatinine level by Cockcroft-Gault formula)
排除标准
- •1) Patients with active double cancer (synchronous double cancer and asynchronous double cancer within 5 years of progression-free period. However, the lesions correspondent to carcinoma in situ of uterine cervix curable by topical treatment, resectable gastric cancer/colorectal cancer by endoscope and topically resectable skin cancer other than malignant melanoma are excluded from active double cancer).
- •2)Patients with anamnesis of drug-induced hypersensitivity.
- •3)Patients with severe postoperative complications (such as postoperative infection, rapture suture).
- •4)Patients with severe complications (such as diarrhoea, intestinal paralysis, ileus, uncontrollable diabetes mellitus, heart failure, kidney failure, liver failure).
- •5)Patients with interstitial pattern recognized as apparent interstitial pneumonia in chest CT.
- •6)Patients with active infection.
- •7)Female patients with pregnant or possibly pregnant (will), or nursing.
- •8)Patients under treatment of type of fluorinated pyrimidine antineoplastic.
- •9)Patients under treatment of flucytosine.
- •10)Any other patients who are regarded as unsuitable for this study by the investigators.
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