NIPH Clinical Trials Search

UMIN ID: C000000085

Registered date:12/09/2005

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)

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedinoperable locally advanced non-small-cell lung cancer
Date of first enrollment2000/07/01
Target sample size200
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)combination chemotherapy of cisplatin and docetaxel with concurrent thoracic radiation therapy combination chemotherapy of mitomycin, vindesine and cisplatin with concurrent thoracic radiation therapy


Primary Outcomeoverall survival
Secondary Outcomeresponse rate progression-free survival pattern of progression/relapse adverse events treatment compliance

Key inclusion & exclusion criteria

Age minimumNot applicable
Age maximum75years-old
GenderMale and Female
Include criteriaHistologically 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
Exclude criteriaPresence 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

Related Information


public contact
Name Katsuyuki Kiura, M.D., Ph.D.
Address 2-5-1 Shikata-cho, Okayama 700-8558 Japan
Telephone 086-235-7225
Affiliation Okayama Lung Cancer Study Group Coordinating Office Respiratory Medicine (Thoracic Oncology)
scientific contact
Name Mitsune Tanimoto, M.D., Ph.D., Professor & Chairman
Address 2-5-1 Shikata-cho, Okayama 700-8558 Japan
Telephone 086-235-7224
Affiliation Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Science Department of Hematology, Oncology, and Respiratory Medicine