non-small cell lung cancer (NSCLC) MedDRA version: 9.1 Level: LLT Classification code 10061873 Term: Non-small cell lung cancer
Conditions
Interventions
Trade Name: VINORELBINE P.FABRE 50
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Vinorelbine
Concentration unit: mg/m2 milligram(s)/square meter
Concentration type: equal
Concentrati
Sponsors
IST - ISTITUTO NAZIONALE PER LA RICERCA SUL CANCRO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent 2. Age > 18 years. 3. ECOG Performance status 10 gr/dl ANC > 1.500/mm3 Platelets> 100.000/mm3 Bilirubin ≤ 2 x ULN AST, ALT, alkaline phosphatase ≤ 3.0 x ULN Creatinine =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: patient refusal treatment not in the best interest of the patient, according to the responsible physician excessive toxicity precluding further therapy, according to the responsible physician treatment delay of more than 2 weeks tumor progression prior chemotherapy pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the tolerability (in terms of drug delivery and toxicity) of cisplatin+vinorelbine and gemcitabine+vinorelbine regimens;Secondary Objective: 1. Time to progression disease 2. Overall survival 3. To achieve a biological markers- based predictive model leading to select patients that could take advantage from this treatment. 4. Tumor biological characterization 5. Integrated evaluation of cardiovascular, respiratory and of quality of life outcome;Primary end point(s): This study is designed, in each arm, according to a Bryant and Day design with the following primary endpoints 1. Success of treatment delivery : to be considered as a ?success? a patient should a. have received 4 cycles of chemotherapy b. with a relative dose intensity over the four cycles of 80% or more for each drug c. have been treated according to the treatment arm allocated at randomization 2. Toxicity: absence of any grade 4 toxicity during chemotherapy | — |
Countries
Italy
Outcome results
None listed