Randomized, comparative clinical study of cisplatin and docetaxel combination chemotherapy and mitomycin, vindesine and cisplatin (MVP) combination chemotherapy with concurrent thoracic radiation therapy for locally advanced unresectable non-small-cell lung cancer (OLCSG0007)

Okayama Lung Cancer Study Group (OLCSG)0 个研究点目标入组 200 人开始时间: 2005年9月12日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•Histologically or cytologically confirmed non-small-cell lung cancer
•No prior therapy
•Age: 75 years or less
•Disease stage of unresectable IIIA (bulky N2) or IIIB
•ECOG performance status of 0 or 1
•Measurable lesion(s)
•Adequate bone marrow function
•WBC 4,000/cmm or more; PLT 100,000/cmm or more
•Adequate liver function
•T Bil 1.5 mg/dl or less; GOT and GPT 2.5 times the upper limit of normal at each institution
•Adequate kidney function
•Creatinine 1.5 mg/dl or less; Ccr 60 ml/min or more
•Adequate pulmonary function
•Pa02 60 Torr or more
•However, this will not apply if there is reduced respiratory function due to stenosis of a main bronchus or a lobar bronchus, and it can be expected that resolution of the stenosis will lead to rapid improvement.
•Acquisition of written informed consent

•Presence of malignant pleural effusion or malignant pericardial fluid
•Presence of pleural dissemination
•Presence of active double cancers
•Even in the case of asynchronous double cancers, the patient will be excluded if there is a past history of chemotherapy or thoracic radiotherapy.
•Presence of serious complications
•1)Interstitial pneumonia
•2)Serious heart disease (e.g., difficult to control angina pectoris, myocardial infarction within the past 3 months, etc.)
•3)Difficult to control diabetes mellitus
•4)Serious infection
•5)Presence of any other complications which can be thought to represent a serious impediment to performance of the therapy
•Pregnancy, breast feeding or the intention to become pregnant

发起方

Okayama Lung Cancer Study Group (OLCSG)