UMIN ID: UMIN000002015
Registered date:30/06/2009
Randomized phase III study of nedaplatin plus docetaxel versus cisplatin plus docetaxel for advanced or relapsed squamous cell carcinoma of the lung
Basic Information
Recruitment status | Complete: follow-up complete |
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Health condition(s) or Problem(s) studied | squamous cell carcinoma of the lung |
Date of first enrollment | 2009/07/01 |
Target sample size | 350 |
Countries of recruitment | Japan |
Study type | Interventional |
Intervention(s) | Nedaplatin at 100mg/m2 plus docetaxel at 60mg/m2 are administered every three weeks. Each three-week treatment schedule is designed as one cycle, and a total of 4 to 6 cycles are administered. Cisplatin at 80mg/m2 plus docetaxel at 60mg/m2 are administered every three weeks. Each three-week treatment schedule is designed as one cycle, and a total of 4 to 6 cycles are administered. |
Outcome(s)
Primary Outcome | Overall survival |
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Secondary Outcome | Progression free survival, response rate and adverse events |
Key inclusion & exclusion criteria
Age minimum | 20years-old |
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Age maximum | 75years-old |
Gender | Male and Female |
Include criteria | |
Exclude criteria | 1)Symptomatic brain metastasis or brain metastasis which needs treatment like adrenal corticosteroids or antiepileptic drugs. 2)Other current active malignancy. 3)Superior vena cava syndrome. 4)Malignant pericardial/ pleural/ peritoneal effusion which need continuous drainage or rapidly increase after temporary drainage. 5)Patient has received radiotherapy to the primary lesion. 6)Patient received palliative radiotherapy except to the primary lesion in last 2 weeks. 7)Patient has a clinically significant con current illness. 8)Interstitial pneumonia or pulmonary fibrosis documented obviously in chest X ray. 9)Pregnant or breast-feeding woman or patient who doesn't agree to contraception. 10)Patient has a history of severe allergy or hypersensitivity. 11)Any other reason that, in the opinion of the investigator, precludes the subject from participating in the study. |
Related Information
Primary Sponsor | West Japan Oncology Group |
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Secondary Sponsor | |
Source(s) of Monetary Support | sanofi-aventis K.K |
Secondary ID(s) |
Contact
public contact | |
Name | Shinichiro Nakamura |
Address | Namba Plaza Bldg.304-1-5-7,Motomachi Naniwa-ku,Osaka556-0016 JAPAN Japan |
Telephone | 06-6633-7400 |
datacenter@wjog.jp | |
Affiliation | West Japan Oncology Group WJOG datacenter |
scientific contact | |
Name | Nobuyuki Yamamoto |
Address | 1007 Shimonagakubo, Nagaizumi-chou, Suntou-gun, Shizuoka, 411-8777, Japan Japan |
Telephone | 055-989-5222 |
nbyamamo@wakayama-med.ac.jp | |
Affiliation | Shizuoka Cancer Center Division of Thoracic Oncology |