Patients affected by stage IIIB or stage IV NSCLC candidates to receive a first line chemotherapy with vinorelbine due to age = 70 and Eastern Cooperative Oncology Group (ECOG) Performance status =2 or age = 70 but ECOG PS = 2 MedDRA version: 15.0 Level: PT Classification code 10029522 Term: Non-small cell lung cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 15.0 Level: PT Classification code 10029521 Term: Non-
Conditions
Interventions
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: VINORELBINE
CAS Number: 71486-22-1
Concentration unit: mg/l milligram(s)/litre
Concentration type: equal
Concentration
Sponsors
ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients affected by stage IIIB or stage IV NSCLC candidates to receive a first line chemotherapy with vinorelbine due to age = 70 and Eastern Cooperative Oncology Group (ECOG) Performance status =2 or age = 70 but ECOG PS = 2 Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 70
Exclusion criteria
Exclusion criteria: 1. Patients who have had previous chemotherapy for lung cancer or radiotherapy on target lesions. 2. Participation in another clinical trial with any investigational agents within 30 days prior to study screening. 3. Presence of infection. 4. Preexisting clinically significant peripheral neuropathy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Patient preference for oral or intravenous vinorelbine, from the 3° cycle onwards;Secondary Objective: Overall Response Rate, Time to Progression, Toxicity, Survival, Subjective reasons for treatment choice.;Primary end point(s): The primary objective of the study was to evaluate patient-reported preference for “oral” or “intravenous” vinorelbine. The primary endpoint was the percentage of patients who preferred the “oral” to the “intravenous” vinorelbine.;Timepoint(s) of evaluation of this end point: 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints are response rate (RR), progression-free survival (PFS), overall survival (OS) and toxicity of both drug formulations. The trial aims to evaluate subjective reasons for treatment choice.;Timepoint(s) of evaluation of this end point: 24 months | — |
Countries
Italy
Contacts
Public Contactdata manager
IRCCS IRST
Outcome results
None listed