NIPH Clinical Trials Search

UMIN ID: C000000287

Registered date:18/11/2005

A Phase III Study of Consolidation Chemotherapy Using UFT plus Cisplatin versus Docetaxel Following Concurrent Chemoradiotherapy for Locally Advanced Non-Small Cell Lung Cancer

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedLocally Advanced Non-Small Cell Lung Cancer
Date of first enrollment2003/06/01
Target sample size150
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)UFT:400mg/m2,p.o.,d1-14,d29-42 Cisplatin:80mg/m2,div,d8,36 Radiation:2Gy*5days/week,d1-40, total 60Gy A: UFT:400mg/m2,p.o.,d1-14 Cisplatin: 80mg/m2,div,d8 every 3-4weeks UFT:400mg/m2,p.o.,d1-14,d29-42 Cisplatin:80mg/m2,div,d8,36 Radiation:2Gy*5days/week,d1-40, total 60Gy B: Docetaxel:60mg/m2,div,d1 every 3weeks


Primary OutcomeSurvival
Secondary OutcomeResponse rate, TTP, Safety, Compliance

Key inclusion & exclusion criteria

Age minimumNot applicable
Age maximum75years-old
GenderMale and Female
Include criteria
Exclude criteria1)bronchopulmonary lymph node metastasis 2) Pleural or pericardial effusion requiring treatment 3) Concomitant malignancy 4) Serious concomitant disease 5)Apparent ineterstitial pneumonia or pulmonary fibrosis 6)Pregnant or lactation women, or women with known or suspected pregnancy. Man who wont let to pregnancy

Related Information


public contact
Address Japan
Affiliation National Kyushu Cancer Center Respiratory
scientific contact
Name Yukito Ichinose
Address 3-1-1 Notame Mimami-ku Fukuoka-shi Fukuoka Japan Japan
Affiliation National Kyushu Cancer Center National Kyushu Cancer Center