JPRN-UMIN000012903
Completed
Phase 2
Randomized phase II study of nab-Paclitaxel (nab-PTX) plus Carboplatin(CBDCA) followed by maintenance nab-PTX or TS-1 plus CBDCA followed by maintenance TS-1 as first-line treatment in patients with stage IIIB/IV squamous cell carcinoma of the lung. - Randomized phase II study of nab-PTX plus CBDCA followed by maintenance nab-PTX or TS-1 plus CBDCA followed by maintenance TS-1.
Internationanl University of Health and Welfare, Respiratory Disease center0 sites58 target enrollmentFebruary 1, 2014
Conditionssquamous cell carcinoma of the lung
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- squamous cell carcinoma of the lung
- Sponsor
- Internationanl University of Health and Welfare, Respiratory Disease center
- Enrollment
- 58
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •1\.History of hypersensitivity to drugs or albumin. 2\.Severe infection 3\.Significant comorbid disease (paresis of intestine, ileus, GI bleeding, uncontrolled angina pectoris, cardiac disease, etc) 4\.Massive pleural and cardiac effusion and ascites required for tube drainage. 5\.Cases of administration in the flucytosine. 6\.Patients with superior vena cava syndrome. 7\.Active synchronous malignant neoplasm. 8\.Interstitial pneumonia or pulmonary fibrosis detectable on Chest X ray. 9\.Brain metastases patients in need of treatment, such as an anti\-seizure medication and steroids or have symptoms. 10\.Cases of post\-radiation to the primary tumor. 11\.Cases of palliative bone or brain irradiation within two weeks of proposed entry to this study. 12\.Uncontrolled psychiatric disease. 13\.Pregnancy, breast feeding and suspected pregnancy. 14\.Other conditions not suitable for this study.
Outcomes
Primary Outcomes
Not specified
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