Local-regionally advanced non-small cell lung cancer. MedDRA version: 9.1 Level: LLT Classification code 10061873 Term: Non-small cell lung cancer
Conditions
Interventions
Trade Name: Navelbine
Product Name: Navelbine 20 mg, 30 mg
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: Vinorelbine
Concentration unit: MBq/mg megabecquerel(s)/milligram
Sponsors
Odense University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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. 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
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this trial is to test a convenient chemotherapy schedule with an oral formulation of radio-sensitizing Navelbine in concurrent chemo-radiotherapy in radical treatment of inoperable locally advanced non small cell lung cancer (stage IIB-IIIB) with radiotherapy. The trial is a randomized phase II study with two doses of radiotherapy. The primary objective of the study is examine the combination of Navelbine oral 150 mg of Vinorelbine administered in 3 weekly doses a week for 6-6½ weeks concomitant with curatively intended irradiation to 60 Gy (2 Gy x 30, 5 F á weeks) or 66 Gy (2 Gy x 33, 5 F á week) starting 3 weeks after two cycles of inductions chemotherapy with Navelbine oral and Carboplatin. Primary endpoint: - Local failure free survival at 9 months after start of radiotherapy ;Secondary Objective: Secondary endpoints - Toxicity - Local tumour control - Overall response rate (CR + PR) - Local tumour control at 9 months evaluated by PET-CT - Overall survival - Disease free survival - Late toxicity ;Primary end point(s): - Local failure free survival at 9 months after start of radiotherapy | — |
Countries
Denmark
Outcome results
None listed