UMIN ID: C000000180
Registered date:12/09/2005
A pilot phaseII study of 3 dimensional stereotactic radiotherapy (3D-SRT) followed by maintenance therapy with oral UFT for stage IB non - small cell lung cancer
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | non - small cell lung cancer, stageIB. |
| Date of first enrollment | 2004/12/01 |
| Target sample size | 30 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Oral UFT 250mg/m2 therapy for two years from the 57th day after 3 dimensional stereotactic radiotherapy (3D-SRT) which consists of consecutive 4 days of 12 Gray irradiation per fraction per day (total 48Gy) |
Outcome(s)
| Primary Outcome | 3-year survival |
|---|---|
| Secondary Outcome | Progression free survival, median survival time, local progression free survival time, local progression free survival at 3 years, pattern of progression or recurrence, adverse events, 5-year survival rate, local progression free survival at 5 years |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 85years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1)Apparent interstitial pneumonitis or fibrosis on chest X ray 2)Irradiation field larger than half of a ipsilateral lung 3)Double cancer within 5 years except for carcinoma in situ, intramucosal tumor, and basal cell carcinoma of the skin 4)History of previous chemotherapy 5)Pregnant woman, lactating woman, woman who has a possibility of pregnancy 6)Uncontrolled angina pectoris, myocardial infarction and congestive heart failure within three months 7)Uncontrolled diabetes mellitus 8)Active infectious disease 9)Fever more than 38 degrees Celsius 10)Steroid administration 11)Other complication unsuitable for the study |
Related Information
| Primary Sponsor | Institute of Biomedical Research and Innovation |
|---|---|
| Secondary Sponsor | Kobe City General Hospital Kobe City West Hospital Nishikobe Medical Center Hyogo Medical Center for Adults |
| Source(s) of Monetary Support | None |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Reiko Naya |
| Address | 2-2 Minatomajima-Minamimachi Chuo-ku Kobe 650-0047, Japan Japan |
| Telephone | 078-304-5200 |
| naya@kcgh.gr.jp | |
| Affiliation | Institute of Biomedical Research and Innovation Department of Translational Research Division of Integrated Oncology |
| scientific contact | |
| Name | Nobuyuki Katakami |
| Address | 2-2 Minatomajima-Minamimachi Chuo-ku Kobe 650-0047, Japan Japan |
| Telephone | 078-304-5200 |
| Affiliation | Institute of Biomedical Research and Innovation Department of Translational Research Division of Integrated Oncology |