Advanced Non-Small Cell Lung Cancer
Conditions
Keywords
lung cancer, chemotherapy, vinorelbine, gemcitabine, carboplatin, advanced lung cancer, non-small cell lung cancer
Brief summary
The purpose of this study is to explore if the combination of vinorelbine and gemcitabine is better than vinorelbine and carboplatin in the treatment of advanced non-small cell lung cancer, in terms of survival, quality of life and need for palliative radiotherapy.
Interventions
DRUGVinorelbine
Day 1: Vinorelbine capsules 60 mg/m2 Day 8: Vinorelbine capsules 60 mg/m2
DRUGGemcitabine
Day 1: Gemcitabine infusion 1000 mg/m2 Day 8: Gemcitabine infusion 1000 mg/m2
DRUGCarboplatin
Day 1: Carboplatin infusion AUC = 5 (Calvert's formula)
Sponsors
The Norwegian Lung Cancer Study Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Non-small cell lung cancer stage IIIB or IV * Not eligible for radical radiotherapy or surgery * WHO performance status 0-2
Exclusion criteria
* Pregnancy * Other clinical active cancer disease * ALAT/ALP more than 3 times upper normal limit, bilirubin \>1.5 upper limit * Bowel disease that causes malabsorption
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| survival | one year |
Secondary
| Measure | Time frame |
|---|---|
| Health related quality of life (HrQoL) | 3 months |
| Toxicity | 3 months |
| Need for palliative radiotherapy | one year |
Countries
Norway
Outcome results
None listed