Docetaxel(D) versus docetaxel plus gemcitabine(DG) for second-line treatment of non-small cell lung cancer (NSCLC) : Results of a JCOG randomized trial (JCOG0104)

UMIN ID: C000000027

Registered date:22/07/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Non-small cell Lung Cancer
• Date of first enrollment: 2002/01/01
• Target sample size: 284
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Docetaxel alone
Docetaxel and Gemcitabine

Outcome(s)

• Primary Outcome: Overall survival
• Secondary Outcome: Adverse events Progression-free survival

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1) Symptomatic brain metastasis 2) Double cancer 3) Superior vena cava syndrom 4) Massive pleural effusion or ascitis 5) Spiral compression 6) Severe hypertension 7) Diabetis melitus treated with insulin 8) Concommitant infectious disease excluded hepatic fever 9) Interstitial lung disease 10) Hypersinsitivity to Polysorbate 80 11) Need to treatment with steroid, ketoconazole, nifedipine or erithromycin 12) Psycologic illness 13) Women during pregbnancy or lacteted

Related Information

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