Navelbine And Radiotherapy in Locally Advanced Lung Cancer

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.

This study is an open label randomized multi-centre phase II trial in patients with inoperable locally advanced stage IIB-IIIB Non Small Cell Lung Cancer who fulfils the general criteria for curatively intended irradiation. The treatment plan consists of two courses of inductions chemotherapy followed of concomitant therapy chemo-radiotherapy 3 weeks after day 1 of the last induction chemotherapy has been given. The patients will be included in the study after completing the induction chemotherapy. Randomization will take place only if an acceptable dose plan can be obtained.

This study was an open label randomized multi-centre phase II trial in patients with inoperable locally advanced stage IIB-IIIB Non Small Cell Lung Cancer who fulfils the general criteria for curatively intended irradiation. The treatment plan consisted of two courses of inductions chemotherapy followed of concomitant therapy chemo-radiotherapy 3 weeks after day 1 of the last induction chemotherapy has been given. The patients was included in the study after completing the induction chemotherapy. Randomization took place only if an acceptable dose plan could be obtained.

Primary endpoint: local recurrence free interval

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