UMIN ID: UMIN000001459
Registered date:29/10/2008
A phase I study of stereotactic body radiation therapy in patients with T2N0M0 non-small cell lung cancer (JCOG0702)
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | T2N0M0 non-small cell lung cancer |
| Date of first enrollment | 2008/10/01 |
| Target sample size | 60 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Stereotactic body radiotherapy |
Outcome(s)
| Primary Outcome | incidence of Grade 2 or more radiation pneumonits within 180 days after stereotactic radiotherapy |
|---|---|
| Secondary Outcome | overall survival, 3-year survival, progression free survival, local progression free survival, 3-year local progression free survival, event free survival, pattern of failure, incidence of Grade 3 or more radiation pneumonitis, adverse events, severe adverse events |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1. apparent interstitial pneumonitis and fibrosis 2. active inflamation without oral drugs 3. double cancer 4. pregnancy 5. psychiatric disorder 6. steroid administration 7. oxygen administration 8. fever of 38.0 degrees centigrade or higher 9. narcotics administration for coughing |
Related Information
| Primary Sponsor | Japan Clinical Oncology Group(JCOG) |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Ministry of Health, Labour and Welfare |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Rikiya Onimaru |
| Address | North14 West5, Kitaku, Sapporo, Hokkaido, 060-8648 Japan Japan |
| Telephone | 011-706-5977 |
| JCOG_sir@ml.jcog.jp | |
| Affiliation | JCOG0702 Coordinating Office Hokkaido University Hospital Radiology Division |
| scientific contact | |
| Name | Hiroki Shirato |
| Address | North14 West5, Kitaku, Sapporo, Hokkaido, 060-8648 Japan Japan |
| Telephone | 011-706-5977 |
| Affiliation | Hokkaido University Hospital Radiology Division |