UMIN ID: UMIN000002035
Registered date:29/06/2009
Phase II Study of TS-1 with Patient-Reported Outcome(PRO) Evaluation in Elderly Patients with Advanced NSCLC
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Non-small cell lung cancer |
| Date of first enrollment | 2009/07/01 |
| Target sample size | 40 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | TS-1:60mg/m2/day-80mg/m2/day |
Outcome(s)
| Primary Outcome | Disease control rate |
|---|---|
| Secondary Outcome | Progression free survival,Overall survival,Patient-Reported Outcome(PRO),Adverse events |
Key inclusion & exclusion criteria
| Age minimum | 75years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1)History of severe allergy 2)Received surgery or radiotherapy to primary region 3)Use of other clinical trial drugs or phenytoin warfarin or flucytosine 4)Serious infection,SIADH,vena cava superior syndrome 5)Serious medical complications 6)Massive pleural effusion,ascites and penicardial effusion requires drainage 7)Symptomatic brain metastasis 8)Require radiotherapy to primary region 9)Concomitant malignancy 10)Intention to be pregnant in the future 11)Other clinical difficulties to this study |
Related Information
| Primary Sponsor | Department of Respiratory Medicine & Rheumatology, Institute of Health Biosciences, The University of Tokushima Graduate School |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | none |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Hisatsugu Goto |
| Address | 3-18-15 Kuramoto-cho, Tokushima, Tokushima 770-8503, Japan Japan |
| Telephone | 088-633-7127 |
| hgoto@tokushima-u.ac.jp | |
| Affiliation | Institute of Health Biosciences,The University of Tokushima Graduate School Department of Respiratory Medicine & Rheumatology |
| scientific contact | |
| Name | Yasuhiko Nishioka |
| Address | 3-18-15 Kuramoto-cho,Tokushima, Tokushima 770-8503, Japan Japan |
| Telephone | 088-633-7127 |
| yasuhiko@tokushima-u.ac.jp | |
| Affiliation | Institute of Health Biosciences,The University of Tokushima Graduate School Department of Respiratory Medicine & Rheumatology |