NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
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
Health condition(s) or Problem(s) studiedneuroblastoma
Date of first enrollment19/12/2011
Target sample size75
Countries of recruitment
Study typeInterventional
Intervention(s)Therapeutic intervention

Outcome(s)

Primary Outcome3 year progression free survival rate (all eligible cases)
Secondary Outcome3-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 minimumNot applicable
Age maximum<= 18age old
GenderBoth
Include criteriaPatients 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

Contact

Public contact
Name tomoko iehara
Address Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto Kyoto Japan 602-8566
Telephone +81-75-251-5571
E-mail 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
E-mail iehara@koto.kpu-m.ac.jp
Affiliation University Hospital Kyoto Prefectural University of Medicine