JPRN-UMIN000001738
Completed
Phase 2
Phase II study of gefitinib therapy inserted by chemotherapy as first line treatment for advanced non-small cell lung cancer harboring epidermal growth factor receptor (EGFR) mutation - Phase II study of gefitinib therapy inserted by chemotherapy for advanced non-small cell lung cancer harboring epidermal growth factor receptor (EGFR) mutation
Thoracic Medical Oncology, National Cancer Center Hospital0 sites33 target enrollmentMarch 1, 2009
Conditionson-small-cell lung cancer
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- on-small-cell lung cancer
- Sponsor
- Thoracic Medical Oncology, National Cancer Center Hospital
- Enrollment
- 33
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •1\) EGFR mutation that associates with gefitinib resistance (exon 20 T790M) or K\-ras mutation 2\) CNS metastasis requiring treatment 3\) Interstitial pneumonitis or pulmonary fibrosis as determined from chest CT 4\) Complications like below a) Active infection b) Acute myocardial infarction, the other severe heart diseases, and arrhythmia within the previous 6months c) Uncontrollable diabetes mellitus d) Uncontrollable hypertension e) Continuous diarrhea and ileus f) Psychological disorders difficult to cooperate in the clinical trial 5\) Receiving systemic corticosteroid therapy 6\) Active metachronous cancer (disease\-free survival of less than 5years) 7\) Pregnancy or breast\-feeding 8\) No intent to practice contraception 9\) Difficult to take medicine continuously
Outcomes
Primary Outcomes
Not specified
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