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Keep this study
Lead
Odense University Hospital
With
Aarhus University Hospital
Vejle Hospital
Copenhagen University Hospital, Rigshospitalet
Aalborg University Hospital
Copenhagen University Hospital at Herlev
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
Age
18–100
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Navelbine And Radiotherapy in Locally Advanced Lung Cancer