UMIN ID: UMIN000001721
Registered date:20/02/2009
Prospective phase II study of stereotactic body radiation therapy using helical tomotherapy for stage IA non-small cell lung cancer.
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | stage IA non-small cell lung cancer |
| Date of first enrollment | 2009/02/20 |
| Target sample size | 50 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | patient number 50, accrual 4 years, follow-up 3years stereotactic body radiation therapy 60Gy/6fraction/8-12 days |
Outcome(s)
| Primary Outcome | 3-year overall survival rate |
|---|---|
| Secondary Outcome | overall survival time, relapse-free survival time, local pregression-free survival time, 3-year local progression free rate, type of recurrence, acute adverse event, late adverse event, ratio of severe adverse event |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | interstitial pneumonitis, lung fibrosis active infection active multiple cancer (last 3 years) pregnancy or breast feeding psychological disorder systemic steroid medication |
Related Information
| Primary Sponsor | Aichi Cancer Center Hospital |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Aichi Cancer Center Hospital |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Natsuo Tomita |
| Address | 1-1 Kanoko-den, Chikusa-ku 464-8681, Nagoya, Aichi Japan |
| Telephone | 052-762-6111 |
| ntomita@aichi-cc.jp | |
| Affiliation | Aichi Cancer Center Hospital Department of Therapeutic Radiation Oncology |
| scientific contact | |
| Name | Takeshi Kodaira |
| Address | 1-1 Kanoko-den, Chikusa-ku 464-8681, Nagoya, Aichi Japan |
| Telephone | 052-762-6111 |
| 109103@aichi-cc.jp | |
| Affiliation | Aichi Cancer Center Hospital Department of Therapeutic Radiation Oncology |