NIPH Clinical Trials Search

UMIN ID: C000000146

Registered date:09/09/2005

Randomiazed controlled trial comparing docetaxel-cisplatin combination with docetaxel alone in elderly patients with advanced non-small-cell lung cancer(JCOG0207)

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiednon-small-cell lung cancer
Date of first enrollment2003/04/01
Target sample size230
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Docetaxel alone administered by 3 consecutive weekly infusions Cispatin and docetaxel administered by 3 consecutive weekly infusions


Primary Outcomeoverall survival
Secondary OutcomeToxicity, Progression-free survival, Response rate, Symptom score

Key inclusion & exclusion criteria

Age minimum70years-old
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteria1) Symptomatic brain metastasis 2) Active another neoplams 3) Severe SVC syndrome 4) Massive pericardial, pleural effusion, or ascites 5) Bone metastasis emergent for palliative radiotherapy or surgery 6) Uncontrollable systemic hypertension 7) Heart failure, Unstable angina Myocardial infarction within 6 months 8) Uncontrollable diabetes 9) Active infection 10) Interstitial pneumonia/ Pulmonary fibrosis 11) Hypersensitivity for polysolbate 80 12) Systemic administartion of corticosteroids

Related Information


public contact
Name Hiroko Tsukada, MD
Address 2-15-3 Kawagishi-cho, Niigata Japan
Telephone 025-266-5111
Affiliation JCOG0207 Coordinating Office Department of internal medicine, Niigata Cancer Center Hospital
scientific contact
Name Akira Yokoyama, MD, PhD
Address 2-15-3 Kawagishi-cho, Niigata Japan
Affiliation Niigata Cancer Center Hospital Department of internal medicine