Older patients with advanced nonsquamous non-small-cell lung cancer
Conditions
Interventions
A Pmetrexed(500mg/m2) given on day1 every 3 weeks in case of low CYFRA-21-1 serum level A Docetaxel(60mg/m2) given on day1 every 3 weeks or Gemcitabine(1,000mg/m2) given on day1, day8 every 3 weeks i
Sponsors
Kyoto Thoracic Oncology Research Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically or cytologically confirmed advanced non-squamous non-small-cell lung cancer 2) No prior chemotherapy 3) Wild type EGFR 4) Clinical stage IIIB (not amenable to curative radiation), IV or recurrent disease 5) With one or more measurable disease or evaluable disease (RECIST ver.1.1) 6) 75 years of age or older 7) Performamne status of 0 or 1 8) Adequate organ function 9) Life expectancy more than 3 months 10) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Squamous cell carcinoma 2) Interstitial pneumonia or pulmonary fibrosis detectable on CT scan 3) History of drug-induced pneumonitis 4) History of poorly controlled pleural effusion,pericardial effusion and ascites 5) No oral supplement of folic acid and no injection of vitamin B12 6) Superior vena cava syndrome 7) Symptomatic brain metastasis 8) Uncontrollable hypertension or diabetes mellitus 9) History of severe heart disease (acute cardiac infarction or unstable angina within 6 months of registration, post-PTCA, post-CABG, sign of heart failure, uncontrollable arrythmia) 10) Severe drug allergy 11) History of active infection 12) Active concomitant cancers 13) Those judged to be not suitable by the attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6-month progression-free survival rate | — |
Countries
Japan
Contacts
Public ContactAkihiro Nishiyama
Kurashiki Central Hospital Department of Respiratory Medicine
Outcome results
None listed