Induction Chemotherapy With Carboplatin and Navelbine Oral(R) Followed by Concomitant Navelbine Oral(R) and Irradiation in Local-regionally Advanced Non-small Cell Lung Cancer. A Randomized Phase II Study.
Inclusion Criteria:
- Age ≥18 years
- Patients with histologically or cytologically documented diagnosis of locally
advanced NSCLC stage IIB to IIIB without pleural effusion
- Performance status 0-1 on the ECOG scale
- Weight loss ≤10% during the last 6 months
- Adequate lung function measured as FEV1 ≥1.0
- Neutrophile count ≥1.5 x 109/L and platelet count ≥100 x 109/L
- Serum bilirubin ≤1.5 upper limit of normal (ULN)
- ALAT ≤2 x ULN
- Able to comply with study and follow-up procedures
- Patients with reproductive potential must use effective contraception
- Written (signed) informed consent to participate in the study
Exclusion Criteria:
- Any unstable systemic disease (including active infection, unstable angina,
congestive heart failure, severe hepatic, renal, or metabolic disease)
- Any other active malignancies within 5 years (except for adequately treated carcinoma
in situ of the cervix or basal or squamous cell skin cancer)
- Prior chemotherapy for lung cancer, including neo- and adjuvant chemotherapy
- Inability to take oral medication, or requirement of intravenous alimentation
- Active peptic ulcer disease
- Nursing mothers