A Multinational, Multicenter, Phase III Open Randomized Trial With or Without Consolidation Chemotherapy Using Docetaxel and Cisplatin After Concurrent Chemoradiation in Inoperable Stage III Non-small Cell Lung Cancer (CCheIN)
Inclusion Criteria:
- 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 Criteria:
- 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