NIPH Clinical Trials Search

UMIN ID: UMIN000000896

Registered date:01/12/2007

A combination phase II study of gemcitabine and S-1 for platinum-refractory patients with non-small cell lung cancer (TORG 0705)

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedNon-small cell lung cancer
Date of first enrollment2007/11/01
Target sample size32
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Chemotherapy S-1 (60 mg/m2, days 1-14, every 3 weeks) Gemcitabine (1,000 mg/m2, days 8 and 15, every 3 weeks) at least 3 courses, until reaching PD


Primary OutcomeOverall response rate
Secondary OutcomeToxicity, Overall survival, Progression free survival, Subset analyses

Key inclusion & exclusion criteria

Age minimumNot applicable
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteria1) Any contraindication for S-1 or gemcitabine. 2) Active concomitant malignancy. 3) Active infectious diseases. 4) Prior resection of primary tumor. 5) Interstitial pneumonia obviously presented by x-ray and/or clinical manifestations. 6) Experience of any pulmonary event during the previous chemotherapy. 7) Prior chemotherapy including any primidine analogue such as 5-FU, tegafur, UFT, S-1, capecitabine, gemcitabine and Ara-C. 8) Brain metastasis with symptoms or requirement of treatment. 9) Requirement of thoracic irradiation. 10) Pleural effusion, ascites or pericardial effusion requiring treatment. 11) Serious abnormalty in ECG. 12) Uncontrolled diabetes mellitus. 13) Women in regnancy, potential pregnancy, or breast feeding. Men willing to cause pregnancy. 14) Other inadequate conditions .

Related Information


public contact
Name Kojima, Hiroyuki
Address 1-45-5, Denn-Enn-Chofu, Ohta-Ku, Tokyo Japan
Telephone 03-3722-5330
Affiliation Thoracic Oncology Research Group Secretariat office
scientific contact
Name Takiguchi, Yuichi
Address 1-8-1, Inohana, Chuo-Ku, Chiba, Japan Japan
Telephone 043-226-2577
Affiliation Chiba University Department of Respirology (B2)