Stage III Non small cell lung cancer
Conditions
Interventions
Trade Name: Navelbine Soft capsule
Product Name: Navelbine soft capsules
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: Vinorelbine tartrate
Sponsors
Pierre Fabre Médicament
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients aged between 18 and 75 years - Histologically or cytologically (fine needle aspiration) proven non-small cell lung cancer (NSCLC) - Untreated locally advanced inoperable stage IIIA (only N2) or Untreated locally advanced inoperable stage IIIB amenable to radical radiotherapy to a dose of 66 Gy - Patients with a Karnofsky Performance Status not less than 80% - Adequate pulmonary function - Life expectancy not less than 12 weeks - Patients without weight loss > 10% within the previous 3 months - Adequate bone marrow, hepatic and renal functions - Presence of at least one measurable lesion (RECIST criteria) 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: - Patients with NSCLC stage IV - Patients with NSCLC stages I, II, IIIA (except N2)· - Patients with NSCLC stage IIIB: with malignant pleural effusion; with tumour extent or location precluding radical radiotherapy as specified in the protocol· - Symptomatic neuropathy (sensory) > grade 1 according to the NCI Common Toxicity Criteria - Hearing impairment not less than Grade 2 - Concomitant/uncontrolled medical disorder (cardiovascular, hepatic or other systemic disease) - Weight loss > 10% within the previous 3 months - Pre-existing malignant pleural effusion - Ascites or pericardial effusion - Active secondary malignancy except appropriately treated carcinoma in situ of the cervix or skin basal cell cancer. Patients with a history of cancer and at least five years of uneventful follow up and no signs of recurrence may be eligible - Previous or concomitant treatment with other anticancer drugs during the last 5 years - Known hypersensitivity to the study drugs or to drugs with similar chemical structures - Concomitant treatment with systemic corticosteroids except chronic treatment lasting more than 1 month at low doses (not less than 20 mg/day of methyl prednisolone or equivalent) - Significant malabsorption syndrome or disease affecting the gastrointestinal tract function - Women if pregnant or breast-feeding or with Positive pregnancy test at inclusion - Male or female of childbearing potential who is unwilling or unable to use a medically accepted method to avoid pregnancy during the study treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare progression-free survival in both arms. ; Secondary Objective: - to evaluate the response rate, overall survival in both arms - to evaluate the safety profile in both arms· - to assess QoL by LCSS ;Primary end point(s): Progression-free survival in both arms | — |
Countries
Germany
Outcome results
None listed