NIPH Clinical Trials Search

UMIN ID: UMIN000001779

Registered date:01/04/2009

Feasibility study of TS-1 after surgery with Cisplatin/Docetaxel in completely resected pathological stage II/IIIA non-small cell lung cancer (TORG0809)

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedNon-small Cell Lung Cancer
Date of first enrollment2009/04/01
Target sample size125
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)After CDDP 80mg/m2 + Docetaxel 60mg/m2, day 1 q3-4w, 3 courses, TS-1 80mg/m2 b.i.d., day 1-14 q3w, more than 6 months, maximum 1 year


Primary Outcometreatment completion proportion
Secondary Outcomeoverall survival, relapse free survival, pattern of recurrence, adverse events

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum75years-old
GenderMale and Female
Include criteria
Exclude criteria1) not recovered from surgical complications 2) active infection such as bacterial infection 3) patients with interstitial pneumonaitis or pulmonary fibrosis, as determined by chest CT 4) patients with myocardial infraction within 6 months 5) patinets with uncontroled complications 6) grade 2 or greater peripheral neuropathy 7) active concomitant malignancy 8) pregnant or lactating woman 9) past history of allergic reactions to polysorbate 80 10) concomitant therapy with flucytocine 11) pneumonectomy 12) other conditions not suitable for this study

Related Information


public contact
Name Seiji Niho
Address 6-5-1, Kashiwanoha, Kashiwa Chiba 277-8577, Japan Japan
Telephone 04-7133-1111
Affiliation National Cancer Center Hospital East Thoracic Oncology Division
scientific contact
Name Norihiko Ikeda
Address 6-7-1, Nishi-shinjuku, Shinjuku-ku, Tokyo 160-0023, JAPAN Japan
Telephone 03-3351-6141
Affiliation Tokyo Medical University Department of Thoracic Surgery