S-1 as second line for non-small cell lung cancer with preexisting interstitial pneumonia: phase II study.
- Conditions
- non-small cell lung cancer
- Registration Number
- JPRN-UMIN000022165
- Lead Sponsor
- Hamamatsu University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 28
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method progression free survival (PFS)
- Secondary Outcome Measures
Name Time Method overall survival 1 year survival rate response rate disease control rate safety incidence of acute exacerbation of preexisting interstitial pneumonia