ORAL VINORELBINE AND CISPLATIN WITH CONCOMITANT RADIOTHERAPY FOLLOWED BY EITHER CONSOLIDATION THERAPY WITH ORAL VINORELBINE AND CISPLATIN PLUS BEST SUPPORTIVE CARE OR BEST SUPPORTIVE CARE ALONE IN STAGE III NON SMALL CELL LUNG CANCER (NSCLC): A RANDOMIZED PHASE III STUDY
- Conditions
- Stage III Non small cell lung cancer
- Registration Number
- EUCTR2004-005135-26-DE
- Lead Sponsor
- Pierre Fabre Médicament
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 376
- 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
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Main Objective: To compare progression-free survival in both arms.<br> ;<br> Secondary Objective: - to evaluate the response rate, overall survival in both arms<br> - to evaluate the safety profile in both arms·<br> - to assess QoL by LCSS<br> ;Primary end point(s): Progression-free survival in both arms
- Secondary Outcome Measures
Name Time Method