Phase II Study of EGFR Status Based Gefitinib Neoadjuvant Therapy in NSCLC Patients
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Non Small Cell Lung Cancer
Both
Non Small Cell Lung Cancer
Trial Information
Phase II Study of EGFR Status Based Gefitinib Neoadjuvant Therapy in NSCLC Patients
Inclusion Criteria:
- Patients pathological diagnosed with NSCLC,with EGFR sensitive mutation;
- Stage IIIA patients with technical operable disease evaluated by image and lab
results;
- Patients without chemotherapy or targeted-therapy before;
- Inform Consent.
Exclusion Criteria:
- Patients with malignant tumor other than lung cancer;
- Patients with other diseases such as cardiovascular disease that may hamper follow
up;
- Patients that may not coordinate well,judged by researcher.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response Rate
Outcome Time Frame:
1 month
Safety Issue:
No
Principal Investigator
Changli Wang, MD
Investigator Role:
Study Director
Investigator Affiliation:
Tianjin Medical University Cancer Institute and Hospital
Authority:
China: Food and Drug Administration
Study ID:
TMU-CIH-LCC-001
NCT ID:
NCT00986284
Start Date:
September 2009
Completion Date:
November 2012
Related Keywords:
- Non Small Cell Lung Cancer
- Non Small Cell Lung Cancer
- Gefitinib
- Neoadjuvant Therapy
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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