advanced non small cell lung cancer in patients over seventy years old
Conditions
Interventions
Trade Name: Oncovin
Pharmaceutical Form:
Sponsors
Institute of oncology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: age over 70 years; cytologically or histologically confirmed NSCLC; ; stage IV; chemo-naive; WHO performance status 0 – 2; standard criteria for platin-based chemotherapy; no other specific therapy is planned Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no 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 120
Exclusion criteria
Exclusion criteria: EGFR and ALK mutations positive Previous chemotherapy WHO performance status 3 or more planned for combined modality treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objectives of the trial: quality of life; treatment side effects;Secondary Objective: Secondary objectives: time to progression, response to treatment according to RECIST; overall survival; treatment costs;Primary end point(s): quality of life; treatment side effects;Timepoint(s) of evaluation of this end point: before treatment, after 3 months , after 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): time to progression, response to treatment according to RECIST; overall survival; treatment costs;Timepoint(s) of evaluation of this end point: median time from registration to first progresion and survival response with RECIST after 3 months | — |
Countries
Slovenia
Outcome results
None listed