UMIN ID: UMIN000000973
Registered date:07/01/2008
An early phase II study of delayed local treatment with surgery and radiation, that follows high dose chemotherapy with peripheral blood stem cell transplantation in patients with advanced neuroblastoma
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Neuroblastoma |
| Date of first enrollment | 2005/12/01 |
| Target sample size | 16 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Chemothrapy, surgery and radiation in INSS satge 4 neuroblastoma |
Outcome(s)
| Primary Outcome | 1-year progression-free survival rate from the 12th week of the protocol |
|---|---|
| Secondary Outcome | 2-year progression-free and overall survival rates, clinical response rate at the 12th week of the protocol and that before surgery, the incidence of adverse events |
Key inclusion & exclusion criteria
| Age minimum | 1years-old |
|---|---|
| Age maximum | 18years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | Active double cancer; pregnant or possiblly pregnant women and those during breast feeding; patients with psychologic disease or symptoms who have difficulty in receiving protocol treatment; patients with disease that may interfere with the protocol treatment |
Related Information
| Primary Sponsor | Japan Neuroblastoma Study Group |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | A research grant from the Ministry of Health, Labour and Welfare: Cancer clinical research project of the year 2009 |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Hiroyuki Shichino |
| Address | 30-1,Oyaguchi-kamichou,Itabashiku,Tokyou,Japan Japan |
| Telephone | 0339728111(2442) |
| shichino.hiroyuki@nihon-u.ac.jp | |
| Affiliation | Nihon University School Of Medicine Division of Pediatrics and Child Health |
| scientific contact | |
| Name | Hideo Mugishima |
| Address | 30-1,Oyaguchi-kamichou,Itabashiku,Tokyou,Japan Japan |
| Telephone | 03-3972-8111(2442) |
| Affiliation | Nihon University School Of Medicine Division of Pediatrics and Child Health |