Prospective randomised clinical phase III trial of (alternating IV and oral) vinorelbine plus cisplatin versus docetaxel plus cisplatin in first line chemotherapy of locally advanced or metastatic non-small-cell lung cnacer patients.
- Conditions
- Treatment in locally advanced or metastatic non-small-lung cancer.
- Registration Number
- EUCTR2004-001904-10-EE
- Lead Sponsor
- Pierre Fabre Medicament represented by IRPF
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 350
- Between 18 years and 75 years
- Histologically or cytologically (fine needle aspiration) proven non-small cell lung cancer, stage IIIB (with supra-clavicular or nodal metastases or pleural effusion), stage IV or relapsing (locally or distant) after a local treatment
- Karnofsky Performance Status not less than 80%
- Life expectancy not less than 12 weeks
- Previously untreated with chemotherapy or immunotherapy
- Adequate bone marrow, hepatic and renal functions
- Presence of at least one measurable indicator lesion (RECIST criteria) which has not been previously irradiated.
Are the trial subjects under 18?
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 a local relapse to be treated by radiation therapy only
- Symptomatic neuropathy (sensory) not less than 1 according to the NCI Common Toxicity Criteria
- Concomitant/uncontrolled medical disorder (cardiovascular, hepatic or other systemic disease)
- Active central nervous disorder, brain metastasis or leptomeningeal involvment
- Weight loss not less than 10% within the previous 3 months
- Superior vena cava syndrome
- Long term oxygen therapy
- Pre-existing symptomatic pleural effusion requiring tapping
- Ascites or pericardial effusion
- Radiotherapy within the previous 4 weeks
- Previous radiotherapy in the only site used to assess response
- Concomitant treatment with any other anticancer drug
- Known hypersensitivity to drugs with similar chemical structures of study drugs
- Concomitant treatment with corticosteroids except chronic treatment lasting more than 1 month, given at low doses (not less than 20mg/day of methylprednisolone or equivalent)
- Significant malabsorption syndrome or disease affecting the gastro-intestinal tract function
- Pregnant or breast-feeding women
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare time to Treatment Failure (TTF) for both regimens;Secondary Objective: To evaluate the response rate, the progression free survival and overall survival in both arms.<br>To evaluate the tolerance in both arms.<br>To assess clinical benefit and to evaluate QOL using LCSS in both arms.;Primary end point(s): Comparative evaluation of the Time to Treatment Failure (TTF) for both regimens.
- Secondary Outcome Measures
Name Time Method