A phase II Study of Carboplatin plus oral S1 in Chemo-Naive Patients with Squamous Cell Lung Cancer (OSAKA-LCSG1102)
- Conditions
- Chemo-Na&iumlve Patients with Squamous Cell Lung Cancer
- Registration Number
- JPRN-UMIN000008083
- Lead Sponsor
- Dept. of Respiratory Medicine, Osaka University Hospital
- Brief Summary
In the 33 patients analyzed, the rate of patients who met the primary endpoint was 30.3% (95% confidence interval: (15.6%-48.7%), and the disease control rate was 75.8%. The median PFS and OS were 3.5 and 11.3 months, respectively. Ten patients received maintenance S-1, and the median PFS from the beginning of induction treatment was 5.3 months. Grade 3/4 toxicities with a frequency of more than 5% were all controllable.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 35
Not provided
1.Adjuvant chemotherapy 2.Pneumonia or Pulmonary fibrosis detectable on chest X-rays. History of drug induced interstitial pneumonia. 3.History of severe drug allergy 4.Active synchronous malignancies 5.Patients with pleural effusion, ascites and/or pericardial effusion requiring drainage 6.Severe complication 7.Metastasis to CNS 8.Patients with chest radiation treatment is required to reach the lung irradiation 9.Treated by flucytosine (5-FC) 10.Women with a possibility of pregnancy, pregnant or lactating 11.Patients whose participation in the trial is judged to be inappropriate by the attending doctor
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response rate
- Secondary Outcome Measures
Name Time Method Progression-free survival, Progression-free survival of maintenance treatment, Overall survival, Frequency and grade of adverse event