NIPH Clinical Trials Search

UMIN ID: UMIN000001244

Registered date:11/07/2008

A phase II randomized trial in completely resected Non-Small-Cell Lung Cancer comparing paclitaxel / carboplatin with docetaxel / cisplatin TORG0503

Basic Information

Recruitment status Complete: follow-up continuing
Health condition(s) or Problem(s) studiedNon-Small-Cell Lung Cancer
Date of first enrollment2006/04/01
Target sample size110
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)A:paclitaxel 200mg/m2 + carboplatin AUC6, day1 q3-4w, 3 courses B: docetaxel 60mg/m2 + cisplatin 80mg/m2, day1 q3-4w, 3 courses


Primary Outcome2-year relapse free survival
Secondary OutcomeOveral survival Incidence of an adverse event QOL(FACT-T) Feasibility

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum70years-old
GenderMale and Female
Include criteria
Exclude criteria1) not recovered from surgical complications 2) active infection such as bacterial infection 3) patients with interstitial pneumonitis or pulmonary fibrosis, as determined by chest CT 4) patients with myocardial infarction within 6 months 5) patients with uncontrolled complications 6) grade 2 or greater peripheral neuropathy 7) active concomitant malignancy 8) pregnant or lactating women 9) past history of allergic reactions to polysorbate 80 10) pneumonectomy 11) bronchoplasty 12) other conditions not suitable for this study

Related Information


public contact
Name Kaoru Kubota
Address 6-5-1, Kashiwanoha, Kashiwa-shi, Chiba 277-8577, Japan Japan
Telephone 04-7133-1111
Affiliation National cancer center east Thoracic Oncology Division
scientific contact
Name Koshiro Watanabe
Address 56, okazawacho, hotogaya, Yokohama-shi, Kanagawa 240-8555, Japan Japan
Telephone 045-331-1961
Affiliation Yokohama municipal citizen's hospital Thoracic Oncology Division