Locally advanced non small cell lung cancer
Conditions
Interventions
Trade Name: Navelbine 20 mg soft capsule
Product Name: Navelbine 20 mg soft capsule
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: Vinorelbine tartrate
CAS Number: 1253 17-39-7
Concentration
Sponsors
PIERRE FABRE MEDICAMENT
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 pN2 confirmed by mediastinoscopy) - Patients with a Karnofsky Performance Status ³ 80% - Adequate pulmonary function - Life expectancy > 12 weeks - Patients without weight loss > 10% within the previous 3 months - Adequate bone marrow, hepatic and renal functions (Neutrophils ³ 2.0 x 109/L-Platelets ³ 100 x 109/L, Haemoglobin ³ 12 g/dL, Total bilirubin £ 1.5 x ULN, Transaminases £ 2.5 x ULN, Alkaline phosphatase =65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Patients with NSCLC stages I, II, bulky IIIA (except pN2 confirmed by mediastinoscopy), IIIB and IV - 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 ³ Grade 2 - Concomitant/uncontrolled medical disorder (cardiac failure or myocardial infarction within the previous 3 months; uncontrolled hypertension or arrhythmia; uncontrolled hypercalcaemia; active infection requiring I.V. antibiotics within 2 weeks before the beginning of treatment) - 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 (£ 20 mg/day of methyl prednisolone or equivalent) - Significant malabsorption syndrome or disease affecting the gastrointestinal tract function and the absorption of oral drugs - 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 2 months preceding the start of study treatment, throughout the study period and at least 3 months following the last dose of study treatment - Participation to another clinical trial with any investigational drug study (whatever the use, curative, prophylactic or diagnostic intent) within 30 days prior to registration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To estimate the effect of CT-RT on pCR in resectable patients;Secondary Objective: - To estimate the effect of CT alone on pCR in marginally resectable patients - To evaluate the clinical OR rate of complete surgery (R0 rate), event free survival and overall survival - To assess tolerance ;Primary end point(s): Pathological complete response rate (pCR) | — |
Countries
Austria, Czech Republic, Finland, Spain
Outcome results
None listed