UMIN ID: UMIN000002383
Registered date:25/08/2009
Feasibility study of adjuvant chemotherapy with S-1 in elderly patients with non-small-cell lung cancer
Basic Information
Recruitment status | Complete: follow-up complete |
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Health condition(s) or Problem(s) studied | non-small-cell lung cancer |
Date of first enrollment | 2009/04/01 |
Target sample size | 25 |
Countries of recruitment | Japan |
Study type | Interventional |
Intervention(s) | Adjuvant chemotherapy of eight courses (2-week administration and 1-week withdrawal): S-1 dose of 67mg/m2 twice daily |
Outcome(s)
Primary Outcome | The percentage of patients who accomplished S-1 therapy of eight courses. |
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Secondary Outcome | Adverse events The relative total administration dose of S-1 |
Key inclusion & exclusion criteria
Age minimum | 70years-old |
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Age maximum | Not applicable |
Gender | Male and Female |
Include criteria | |
Exclude criteria | 1)Past history of drug hypersensitivity 2)Past history of myocardial infarction within 6 months 3)Interstitial pneumonia or active lung fibrosis 4)Uncontrolled heart diseases 5)Uncontrolled psychiatric disorders 6)Uncontrolled diabetes 7)Bowel problems 8)Active infection 9)Severe complications 10)Active concomitant malignancy |
Related Information
Primary Sponsor | Lung Oncology Group in Kyushu, Japan (LOGIK) |
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Secondary Sponsor | |
Source(s) of Monetary Support | Clinical Research Support Center kyushu |
Secondary ID(s) |
Contact
public contact | |
Name | Noriyuki Ebi |
Address | Japan |
Telephone | 0948-22-3800 |
Affiliation | Iizuka Hospital Department of respiratory medicine |
scientific contact | |
Name | Yukito Ichinose |
Address | Fukuoka Japan |
Telephone | 092-541-3231 |
Affiliation | National Kyushu Cancer Center Department of Thoracic Oncology |