Non-small cell lung cancer
Conditions
Interventions
Four cycles of Carboplatin(AUC 5, Day 1)+ S-1 (80mg/m2/day, 2week on/2week off) followed by maintenance S-1 monotherapy in 4-week cycles until progression disease
Sponsors
Okayama Lung Cancer Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically or cytologically confirmed non-small-cell lung cancer with Chemo-naive patients 2) Patients who have measurable lesion or evaluable lesion by RECIST 3) Patients with Chemo-naive patients Stage three/four without any indications for radiotherapy 4) Patients aged over 70 years old 5) ECOG PS 0-2 6) Patients who have measurable lesion or evaluable lesion by RECIST 7) Adequate bone mallow function, evaluated within 14 days before enrollment (registration day is day1, and on the same day two weeks ago, is impossible) as WBC >= 3,000/mm3 Neu >= 1,500/mm3 Plt >= 150,000/mm3 Hb >= 9 g/dL 8) Adequate liver function T.Bil <= 1.5 mg/dL AST/ALT <= 2.5 * upper limit of normal 9) Adequate renal function Serum Cr <= upper limit of normal. 10) Adequate pulmonary function PaO2 >= 60 Torr or SpO2 >= 90 % (both at rest and room air) 11) Patients who underwent palliative radiation therapy within one week were excluded 12) Patients who are able to take orally 13) Written informed consent from the patients
Exclusion criteria
Exclusion criteria: 1) Patients with brain metastases with the clinical symptoms 2) Patients with disease-free interval is less than five years without treatment and even in patients with cancer or metachronous duplication of activity 3) Patients who underwent radiation therapy within one weeks (a palliative radiation therapy to the lesion, e.g. bone metastasis, was excepted from this exclusion) 4) Patients with a history of severe drug allergy 5) Pregnancy, breast feeding or wish of future bearing 6) Patients with severe complication Interstitial pneumonia or pulmonary fibrosis detectable on Chest X-ray History of severe heart disease (uncontrollable arrhythmia, uncontrollable angina pectoris, congestive heart failure, etc. within 3 months) Uncontrollable diabetes mellitus Patients with severe infection Patients has pleural effusion, pericardial effusion and ascites to be treated 7) Patients who need to be treated by radiotherapy in an urgent 8) concomitant therapy with other pyrimidine fluoride antineoplastic agents 9) concomitant therapy with warfarin 10) concomitant therapy with dabigatran etexilate 11) Principal investigator cases that are deemed inappropriate
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival, Overall Survival, Quality of Life, Adverse Event, Effects of complication, Compliance with Treatment | — |
Primary
| Measure | Time frame |
|---|---|
| Response Rate | — |
Countries
Japan
Contacts
Public ContactKatsuyuki Hotta
Okayama University Hospital Department of Respiratory Medicine
Outcome results
None listed