non-small cell lung cancer
Conditions
Interventions
S-1, day 1- 28, q6w. body surface area (BSA) >
1.5m2 S-1 80 mg/day BSA 1.25 - 1.5m2 S-1 100 mg/day BSA >
1.5m2 S-1 120 mg/day
Sponsors
Hamamatsu University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) pathologically confirmed non small cell lung cancer 2) stage IIIB/IV or relapsed patients who received anti-cancer agents once. 3) patients with preexisting interstitial pneumonia 4) more than 20 years old 5) ECOG PS 0-2 6) life expectancy for more than 3 months 7) more than one measurable lesion 8) ability to take medications per oral 9) preserved main organs function 10) Informed consent with documents by participants.
Exclusion criteria
Exclusion criteria: 1) deterioration of preexisting interstitial pneumonia within 3 months (acute/sub-acute cases) 2) history of acute exacerbation of preexisting interstitial pneumonia or drug induced lung injury. 3) taking corticosteroids more than 15 mg/day of prednisolon or equal 4) taking immunosuppressant 5) received irradiation to lung within 3 months 6) using home oxygen therapy (HOT) 7) history of treatment with fluorinated pyrimidine 8) contraindicated for S-1 9) symptomatic, unstable brain metastasis 10) with pleural or peritoneal effusions which need to be drainage 11) with watery diarrhea 12) with severe comorbidities considered to be obstacle for anti-cancer therapy. 13) with metachronous or synchronous multiple cancer 14) using flucytosine 15) being pregnant or have an intention to be or make pregnant, or breast feeding. 16) considered as inappropriate to be participant by the primary physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival (PFS) | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival 1 year survival rate response rate disease control rate safety incidence of acute exacerbation of preexisting interstitial pneumonia | — |
Countries
Japan
Contacts
Public ContactNorimichi Akiyama
Hamamatsu University School of Medicine 2nd division, Department of Internal Medicine
Outcome results
None listed