A Phase II Clinical Trial of CBDCA and TS-1 concurrent chemotherapy followed by TS-1 Maintenance Therapy for Advanced and Recurrent Squamous Cell Lung Cancer: SMILE Trial
- Conditions
- on-small cell lung cancer (squamous cell carcinoma)
- Registration Number
- JPRN-UMIN000007242
- Lead Sponsor
- ational Hospital Organization Shikoku Cancer Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 30
Not provided
1) Any previous first line treatment with radiotherapy (including chemo radiotherapy) 2) Administration contraindication to Carboplatin and S-1. 3) Severe complications, such as cardiac failure, renal failure, hepatic failure, hemorrhagic gastric or duodenal ulcer, ileus, and uncontrollable or insulin-treated diabetic. 4) Severe drug allergies or history of drug hypersensitivity 5) Symptomatic or apparent interstitial pneumonia/lung fibrosis on CT scan or X-ray image findings (Included positive suspicion or history of them). 6) Severe watery diarrhea 7) With active infection. Fever higher than 38 degrees celsius. 8) HBsAg positive patients 9) The brain metastases which require emergent treatment. 10) Patients with ascites, pleural or pericardial effusion requiring drainage. 11) Patients undergoing UFT or TS-1 adjuvant therapy. The case postoperative recurrence within 6 months after adjuvant therapy. 12) Active concomitant malignancy with disease-free duration to be within 3 years. 13) Required to continue Flucytosine (5- FC), phenytoin and warfarinpotassium. 14) Pregnant, lactating or women of child-bearing potential. Men who want get partner pregnant. 15) The case that is judged to be inadequacy for this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1-year survival rate
- Secondary Outcome Measures
Name Time Method Progression free survival(PFS) Overall survival (OS) Objective response rate (ORR) Safety