JPRN-jRCTs031180401进行中（未招募）2 期
A multicentre, single arm, confirmatory trial to evaluate the effectiveness of induction CDDP plus TS-1 with concurrent radiotherapy (66Gy) followed by surgical resection in patients with superior sulcus tumor.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- Suzuki Kenji
- 入组人数
- 60
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) Histologically or cytologically proven non-small cell lung cancer, diagnosed using specimen material obtained from primary tumor or metastastatic lymph node
- •(2) Chest MRI or thoracic CT, direct invasion of the primary lesion to the organ of one of the following is suspected.
- •a) Invasion to the first rib or more superior chest wall
- •b) Subclavian vein or subclavian artery
- •(3) cN0, cN1
- •(4) Patients with evaluable lesions or measurable disease
- •(5) 20years or more, 75 years or less
- •(6) ECOG PS 0-1
- •(7) Expected FEV 1.0 > 800ml after lung resection , SpO2 (Room air) >95%
- •(8) Adequate organ function
- •(9) Written informed consent
排除标准
- •(1) Distant metastasis
- •(2) malignant pleural effusion, pericardial effusion, intrathoracic seeding.
- •(3) Uncontrollable systemic disease (hyper tension, diabetes mellitus etc.)
- •(4) Case with the administration of the flucytosine.
- •(5) Severe drug allergy
- •(6) Infection requiring intravenous administration of anti-viral agents antibiotics, or antifungals
- •(7) Hepatitis Bs antigen positive
- •(8) History of severe heart disease , Current or previous (within the last 1 year) history of myocardial infarction
- •(9) Traumatic fracture of unrecovery ,a high degree of wound
- •(10) Severe diarrhea
- •(11) Investigational new drug or the unapproved drug is administered
- •(12) Interstitial pneumonia or pulmonary fibrosis detectable on chest CT
- •(13) History of active double cancer
- •(14) History of pregnancy or lactation or Women suspected of being pregnant.Men who wish to make a child. or no intention to contraception
- •(15) Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator
研究者
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