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.
Phase 2
- Conditions
- on-Small-Cell Lung Cancer
- Registration Number
- JPRN-UMIN000001863
- Lead Sponsor
- Central Japan Lung Study Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 19
Inclusion Criteria
Not provided
Exclusion 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response rate
- Secondary Outcome Measures
Name Time Method Disease control rate, Median survival time, 1-year survival rate, Progression-free survival time, Quality of life, Adverse events