JRCT ID: jRCTs051180203
Registered date:27/03/2019
A phase 2 study for intermediate risk neuroblastoma based on IDRF (Image Defined Risk Factors)
Basic Information
Recruitment status | Not Recruiting |
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Health condition(s) or Problem(s) studied | neuroblastoma |
Date of first enrollment | 19/12/2011 |
Target sample size | 75 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | Therapeutic intervention |
Outcome(s)
Primary Outcome | 3 year progression free survival rate (all eligible cases) |
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Secondary Outcome | 3-year progression-free survival rate (localized group, distant metastasis group), 3 year overall survival rate (all eligible cases, localized and metastatic group), Clinical response rate, histologic response rate, adverse event occurrence rate |
Key inclusion & exclusion criteria
Age minimum | Not applicable |
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Age maximum | <= 18age old |
Gender | Both |
Include criteria | Patients with INSS stage 3 without MYCN amplification, who include children over12 months with favorable histology and 12 to 18 months with unfavorable histology. Patients with INSS stage 4 without MYCN amplification, who include children under 12 months and 12 to 18 months with favorable histology and DNAindex>1 Patients with INSS stage 4s without MYCN amplification, who include children under 12 months with unfavolable histology or favorable histology and DNAindex=1 |
Exclude criteria | (1) duplicated cancer cases. (2) A pregnant woman or a woman who may be pregnant or a lactating woman. (3) cases are merging psychoses or psychiatric symptoms. (4) cases who considers a disease, severe complication, or severe malformation that a doctor deems inappropriate to participate in this study. (5) cases of respiratory failure requiring intubation, cases with coagulopathy presenting DIC and the like |
Related Information
Primary Sponsor | iehara tomoko |
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Secondary Sponsor | Tajiri Tatsuro |
Source(s) of Monetary Support | |
Secondary ID(s) | UMIN000004700 |
Contact
Public contact | |
Name | tomoko iehara |
Address | Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto Kyoto Japan 602-8566 |
Telephone | +81-75-251-5571 |
iehara@koto.kpu-m.ac.jp | |
Affiliation | Kyoto Prefectural University of Medicine |
Scientific contact | |
Name | tomoko iehara |
Address | 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, JAPAN. Kyoto Japan 602-8566 |
Telephone | +81-75-251-5571 |
iehara@koto.kpu-m.ac.jp | |
Affiliation | University Hospital Kyoto Prefectural University of Medicine |