UMIN ID: UMIN000001863
Registered date:08/04/2009
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.
Basic Information
Recruitment status | Complete: follow-up complete |
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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 |
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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 |
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Age maximum | Not applicable |
Gender | Male and Female |
Include criteria | |
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 |
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Secondary Sponsor | |
Source(s) of Monetary Support | None |
Secondary ID(s) |
Contact
public contact | |
Name | Kosuke Takahashi |
Address | 18 Kuriyado kake-machi, Okazaki Aichi 444-0011, Japan Japan |
Telephone | 0564-21-6251 |
Affiliation | Aichi Cancer Center Aichi Hospital Department of Respiratory Medicine |
scientific contact | |
Name | Hiroshi Saito |
Address | 18 Kuriyado kake-machi, Okazaki Aichi 444-0011, Japan Japan |
Telephone | 0564-21-6251 |
Affiliation | Aichi Cancer Center Aichi Hospital Department of Respiratory Medicine |