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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.

Phase 2
Conditions
squamous cell carcinoma of the lung
Registration Number
JPRN-UMIN000012903
Lead Sponsor
Internationanl University of Health and Welfare, Respiratory Disease center
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
58
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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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