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.

未提供0 个研究点目标入组 60 人开始时间: 2014年8月7日最近更新: 2025年6月17日

试验速览

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•(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

•(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

3-year overall survival

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发起方

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