Induction chemotherapy with Carboplatin and Navelbine Oral® followed by concomitant Navelbine Oral® and irradiation in local-regionally advanced non-small cell lung cancer. A randomized phase II study.

Odense University Hospital0 个研究点开始时间: 2009年1月21日最近更新: 2017年8月21日

试验速览

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•- 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.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Exclusion criteria
•Patients who meet any of the following exclusion criteria are not to be enrolled in this study:
•-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.

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