A Phase II study of Gefitinib as First-Line Treatment for Elderly Patients with Non-Small-Cell Lung Cancer Harboring Epidermal Growth Factor Receptor Mutations.

UMIN ID: UMIN000001863

Registered date:08/04/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Non-Small-Cell Lung Cancer
• Date of first enrollment: 2009/04/01
• Target sample size: 19
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Gefitinib treatment

Outcome(s)

• Primary Outcome: Response rate
• Secondary Outcome: Disease control rate, Median survival time, 1-year survival rate, Progression-free survival time, Quality of life, Adverse events

Key inclusion & exclusion criteria

• Age minimum: 70years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1) Active infection, uncontrolled heart disease or diabetes mellitus 2) Interstitial pneumonia / pulmonary fibrosis on computed tomography scan 3) Massive pleural or pericardial effusion, or ascites 4) Superior vena cava syndrome 5) Symptomatic brain metastases 6) Severe drug allergy 7) Previous radiotherapy to the primary tumor 8) Postoperative adjuvant therapy 9) Other concurrent active malignancy 10) Pregnant or breast-feeding woman

Related Information

• Primary Sponsor: Central Japan Lung Study Group
• Source(s) of Monetary Support: None