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

UMIN ID: C000000146

Registered date:09/09/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: non-small-cell lung cancer
• Date of first enrollment: 2003/04/01
• Target sample size: 230
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Docetaxel alone administered by 3 consecutive weekly infusions
Cispatin and docetaxel administered by 3 consecutive weekly infusions

Outcome(s)

• Primary Outcome: overall survival
• Secondary Outcome: Toxicity, Progression-free survival, Response rate, Symptom score

Key inclusion & exclusion criteria

• Age minimum: 70years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1) 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

• Primary Sponsor: Japan Clinical Oncology Group(JCOG)
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare
• Secondary ID(s): NCT00190476