Randomiazed controlled trial comparing docetaxel-cisplatin combination with docetaxel alone in elderly patients with advanced non-small-cell lung cancer(JCOG0803/WJOG4307L)

UMIN ID: UMIN000001424

Registered date:10/10/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: non-small-cell lung cancer
• Date of first enrollment: 2008/10/01
• Target sample size: 380
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

A : 3-weekly docetaxel alone
B : Weekly docetaxel+cisplatin combination

Outcome(s)

• Primary Outcome: overall survival
• Secondary Outcome: adverse events, progression-free survival, response rate, complete 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 other than viral hepatitis 10) Hepatitis B virus infection 11) Interstitial pneumonia/ Pulmonary fibrosis 12) Hypersensitivity for polysolbate 80 13) Systemic administartion of corticosteroids

Related Information

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