UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005045 |
|---|---|
| Receipt number | R000005976 |
| Scientific Title | A Phase II Study of Delayed Local Treatment for High Risk Neuroblastoma |
| Date of disclosure of the study information | 2011/02/07 |
| Last modified on | 2019/03/29 12:58:07 |
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Basic information
Public title
A Phase II Study of Delayed Local Treatment for High Risk Neuroblastoma
Acronym
Delayed Local Treatment Study for High Risk Neuroblastoma
Scientific Title
A Phase II Study of Delayed Local Treatment for High Risk Neuroblastoma
Scientific Title:Acronym
Delayed Local Treatment Study for High Risk Neuroblastoma
Region
| Japan |
Condition
Condition
High Risk Neuroblastoma
Classification by specialty
| Hematology and clinical oncology | Surgery in general | Pediatrics |
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy and toxicity of delayed local treatment with surgery and radiation, following bone marrow ablative high-dose chemotherapy and autologous hematopoietic stem cell transplantation, in children between 0.5 to 18 years old with COG high risk neuroblastoma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
3-year progression-free survival rate
Key secondary outcomes
3-year overall survival rate, the incidence of adverse events, clinical response rate before surgery
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
Chemotherapy, surgery and radiation in high risk neuroblastoma
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 1 | years-old | <= |
Age-upper limit
| 18 | years-old | > |
Gender
Male and Female
Key inclusion criteria
High risk neuroblastoma patients aged between 0.5 to 18 years old
Key exclusion criteria
Active double cancer; pregnant or possibly pregnant women and those during breast feeding; patients with psychological disease or symptoms who have difficulty in receiving protocol treatment; patients with disease that may interfere with the protocol treatment
Target sample size
66
Research contact person
Name of lead principal investigator
| 1st name | Hideo |
| Middle name | |
| Last name | Mugishima |
Organization
Nihon University School of Medicine
Division name
Division of Pediatrics and Child Health
Zip code
173-8610
Address
30-1,Oyaguchi-kamichou,Itabashiku,Tokyou,Japan
TEL
03-3972-8111(2442)
mugishimahideo@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Shichino |
Organization
National center For Global Health and Medicine
Division name
Division of Pediatrics
Zip code
1620052
Address
1-21-1 Toyama Shinjuku-ku Tokyo Japan
TEL
0332027181
Homepage URL
http://www.jnbsg.jp/
hshichino@hosp.ncgm.go.jp
Sponsor or person
Institute
Japan Neuroblastoma Study Group
Institute
Department
Personal name
Funding Source
Organization
A research grant from the Ministry of Health, Labor and Welfare: Cancer clinical research project of the year 2010
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
A research grant from the Ministry of Health, Labor and Welfare: Scientific research project of the year 2010
Name of secondary funder(s)
A research grant from the Ministry of Health, Labor and Welfare: Cancer clinical research project of the year 2010
IRB Contact (For public release)
Organization
Nihon University, Itabashi Hospital
Address
0063
Tel
03-3972-8111
hshichino@hosp.ncgm.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
札幌北楡病院（北海道）、北海道立子ども総合医療・療育センター（北海道）、山形大学医学附属病院（山形県）、福島県立医科大学病院（福島県）、獨協医科大学とちぎこども医療センター（栃木県）、茨城県立こども病院（茨城県）、群馬大学医学部附属病院（群馬県）、群馬県立小児医療センター（群馬県）、順天堂大学医学部附属順天堂医院（東京都）、帝京大学医学部附属病院（東京都）、聖路加国際病院（東京都）東京都立小児総合医療センター（東京都）、日本大学医学部附属板橋病院（東京都）、静岡県立こども病院（静岡県）、長野県立こども病院（長野県）、京都大学医学部附属病院（京都府）、北野病院（京都府）、近畿大学医学部奈良病院（奈良県）、滋賀医科大学医学部附属病院（滋賀県）、兵庫県立こども病院（兵庫県）、神戸大学医学部附属病院（兵庫県）、兵庫医科大学病院（兵庫県）、川崎医科大学附属病院（岡山県）、島根大学医学部附属病院（島根県）、熊本赤十字病院（熊本県）、大分大学医学部附属病院、福岡大学病院（福岡県）、宮崎大学医学部附属病院（宮崎県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 02 | Month | 07 | Day |
Related information
URL releasing protocol
http://www.jnbsg.jp/
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
75
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2011 | Year | 02 | Month | 04 | Day |
Date of IRB
| 2011 | Year | 03 | Month | 28 | Day |
Anticipated trial start date
| 2011 | Year | 03 | Month | 28 | Day |
Last follow-up date
| 2018 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 02 | Month | 07 | Day |
Last modified on
| 2019 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005976
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| Registered date | File name |
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