Non-Small Cell Lung Cancer
Conditions
Keywords
Elder Patients, Non-Small Cell Lung Cancer, Previously Untreated, Advanced
Brief summary
A comparison of biweekly combination chemotherapy (gemcitabine plus carboplatin) with weekly gemcitabine in elder patients (\> 75) with previously untreated advanced non-small cell lung cancer. Primary objective is to determine the objective response rate (CR+PR by RECIST criteria) for biweekly gemcitabine and carboplatin combination chemotherapy versus weekly single gemcitabine as first-line therapy in elder advanced non-small lung cancer patients (\> 76 years) who have received no prior treatment for non-small lung cancer. As secondary objectives, adverse event profile, tolerability of biweekly gemcitabine and carboplatin combination chemotherapy, progression-free survival and overall survival will be evaluated in both patients with biweekly gemcitabine and carboplatin combination chemotherapy and weekly single gemcitabine. The study hypothesis is that biweekly combination chemotherapy of gemcitabine plus carboplatin may improve the efficacy.
Interventions
Gemcitabine 1000mg/m2, DIV on day 1 and 15 of each 28 day cycle. Carboplatin AUC=3, DIV on day 1 and 15 of each 28 day cycle. Number of cycles: until progression or unacceptable toxicity develops, up to 6 cycles.
DRUGGemcitabine
Gemcitabine 1000mg/m2, DIV on day 1, 8 and 15 of each 28 day cycle. Number of cycles: until progression or unacceptable toxicity develops, up to 6 cycles
Sponsors
Hamamatsu University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
76 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of histologically confirmed stage IIIB or IV non-small cell lung cancer * Good performance status (ECOG 0-1) * No previous treatment * Age 76 years and older * Adequate bone marrow, liver and renal functions * No pregnant * Measurable disease, defined as at least one lesion whose longest diameter can be accurately measured as \>=1.0 cm by spiral CT scan * Provided written informed consent
Exclusion criteria
* Severe complications or a concomitant malignancy * Prior and other concurrent radiotherapy, chemotherapy, immunotherapy, EGFR tyrosine kinase inhibitors * Interstitial pneumonia or lung fibrosis * Contraindicated gemcitabine or carboplatin * Inappropriate patients for entry to this study, judged by the physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy (response rate) | two-years, followed RECIST criteria |
Secondary
| Measure | Time frame |
|---|---|
| The toxicity profile (adverse event profile) | two-years, followed NCI-CTCAE criteria |
Countries
Japan
Outcome results
None listed