UMIN ID: UMIN000001755
Registered date:05/03/2009
Randomized phase 3 trial of prophylactic cranial irradiation for patients with extensive small-cell lung cancer
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Extensive small-cell lung cancer patients with no brain metastasis who had a response to platinum-based first-line chemotherapy, |
| Date of first enrollment | 2009/03/01 |
| Target sample size | 330 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Prophylactic cranial irradiation 25Gy (2.5 Gy X 10frs) No therapy |
Outcome(s)
| Primary Outcome | Overall survival |
|---|---|
| Secondary Outcome | Incidence of brain metastasis, Time to brain metastasis, Progression free survival, Adverse events |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1. Previous radiotherapy to the head and neck area overlapped with PCI field. 2. Another active cancer 3. Serious psychological and/or physiological complications 4. An expectant or lactating woman |
Related Information
| Primary Sponsor | Yamamoto Group, Grant for Cancer Research, Ministry of Health, Labour, and Welfare |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Ministry of Health, Labour, and Welfare |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Toshiaki Takahashi |
| Address | 1007 Shimonagakubo Nagaizumi-cho Sunto-gun, Shizuoka, 411-8777 Japan |
| Telephone | 055-989-5222 |
| t.takahashi@scchr.jp | |
| Affiliation | Shizuoka Cancer Center Division of Thoracic Oncology |
| scientific contact | |
| Name | Nobuyuki Yamamoto |
| Address | 811-1, Kimiidera,Wakayama City,Wakayama, 641-8509, Japan Japan |
| Telephone | 073-441-0619 |
| nbyamamo@wakayama-med.ac.jp | |
| Affiliation | Wakayama Medical University Third department of Internal Medicine |