A phase 2 study for intermediate risk neuroblastoma based on IDRF (Image Defined Risk Factors)

JRCT ID: jRCTs051180203

Registered date:27/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: neuroblastoma
• Date of first enrollment: 27/03/2019
• Target sample size: 75
• Study type: Interventional
• Intervention(s): Therapeutic intervention

Outcome(s)

• Primary Outcome: 3 year progression free survival rate (all eligible cases)
• 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
• 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
• Secondary Sponsor: Tajiri Tatsuro
• Secondary ID(s): UMIN000004700