patients underwent complete surgery for non small cel lung cancer MedDRA version: 9.1 Level: LLT Classification code 10029517 Term: Non-small cell lung cancer stage I
Conditions
Interventions
Trade Name: NAVELBINE
Pharmaceutical Form: Solution for infusion
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Trade Name: CISPLATINO TEVA
Pharmaceutical For
Sponsors
OSPEDALE S. RAFFAELE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: istologic and citologic documentation about NSCLC;previous surgery for complete eradication of non small cell lung cancer (level TNM IB,II,IIIA9,surgery within 2 months before the enrollment; performance status ECOG01; age >= 18; patients with normal reserve of marrow; patients with adequate epatic and renal function;patients withouth ongoing cardiac patologies or angina or heart block on therapy, no stroke within 6 months from enrollment; written informed consent 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: other previous or concomitant malign patologies, apart from cutaneous basalioma and utero's carcinoma on adequate therapy; uncontrolled active infections;periferic neuropathy level 2;pregnancy or presumed pregnancy; difficulties for FU due to geografical distance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: evaluation of the toxicity of the new chwmiotherapic schedule cisplatino-vinorelbine in patients undrwent complete surgery for lung cancer not small cell and of the compliance to treatment;Secondary Objective: evaluation of the activity , as far as the time of relapse is concerned, and of the medium and global survival (from the beginning of the tretment to the death date for every cause o to the date of the last FU). evaluation of the quality of life.;Primary end point(s): time out of illness counted from the date of the beginning of treatment to the date of relapse or death for any cause or to the last FU; -the duration of a partial response will be calculated from the beginning of treatment to the relapsing of the patology;the survival will be calculated from the beginning of treatment. | — |
Countries
Italy
Outcome results
None listed