Status:
COMPLETED
Efficacy Study of Additional Chemotherapy After Concurrent Chemoradiation in Non-small Cell Lung Cancer
Lead Sponsor:
Samsung Medical Center
Collaborating Sponsors:
Sanofi
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Non-Small Cell Lung Cancer(NSCLC) is the leading cause of death in Korean men after stomach cancer. Surgical resection plays a main role for curative treatment. However, less than 20 % of the NSCLC pa...
Eligibility Criteria
Inclusion
- Histologically proven non-small cell lung cancer
- Presence of measurable disease by RECIST
- Inoperable Stage IIIA or IIIB, proven by CT or MRI (except wet T4). However, N2 or N3 should be confirmed by PET or pathology. (For T4, PET is optional)
- 18 years of age or older
- ECOG Performance status 0-1
- No prior chemotherapy, radiation therapy to chest, immunotherapy, or biologic therapy
- Serum Hgb ≥ 10 gm/dL, platelet ≥ 100,000/μL, absolute neutrophil count ≥ 1,500/μL
- Serum creatinine ≤1.25 x UNL or creatinine clearance ≥60 mlmL/min
- Serum bilirubin ≤ 1.5 x UNL, AST (SGOT) and ALT (SGPT) ≤ 2.5 x UNL, alkaline phosphatase ≤ 5 x UNL
- FEV1\> 0.8 L
- Patients must sign an informed consent
Exclusion
- Carcinoid tumor, small cell carcinoma of lung
- Patients with any distant metastasis
- History of another malignancy within the last five years except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix
- Any other morbidity or situation with contraindication for chemotherapy (e.g. active infection, myocardial infarction preceding 6 months, symptomatic heart disease including unstable angina, congestive heart failure or uncontrolled arrhythmias, immunosuppressive treatment)
- Pregnant or lactating women, women who has not taken test of pregnancy (within 14 days before the first administration) and pregnant women
- Women and men of childbearing potential who have no willing of employing adequate contraception
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
434 Patients enrolled
Trial Details
Trial ID
NCT00326378
Start Date
October 1 2005
End Date
May 1 2015
Last Update
June 8 2015
Active Locations (1)
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1
Samsung Medical Center
Seoul, South Korea, 135-710