UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001044 |
|---|---|
| Receipt number | R000001234 |
| Scientific Title | A late phase II study of multidisciplinary approach to establish standard treatment for advanced neuroblastoma |
| Date of disclosure of the study information | 2008/02/20 |
| Last modified on | 2012/10/03 13:21:47 |
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Basic information
Public title
A late phase II study of multidisciplinary approach to establish standard treatment for advanced neuroblastoma
Acronym
A late phase II study to establish standard treatment for advanced neuroblastoma
Scientific Title
A late phase II study of multidisciplinary approach to establish standard treatment for advanced neuroblastoma
Scientific Title:Acronym
A late phase II study to establish standard treatment for advanced neuroblastoma
Region
| Japan |
Condition
Condition
neuroblastoma
Classification by specialty
| Hematology and clinical oncology | Surgery in general | Pediatrics |
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and toxicity of induction chemotherapy, surgery, myeloablative chemotherapy with autologous hematopoietic stem cell rescure and radiotherapy for advanced neuroblastoma aged between 1 to 18 years old.
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
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 |
Interventions/Control_1
Chemotherapy, surgery and radiotherapy for high-risk neuroblastoma patients
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 1 to 18 years old
Key exclusion 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
Target sample size
37
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masa-aki Kumagai |
Organization
National Center for Child Health and Development
Division name
Division of Hematology
Zip code
Address
2-10-1 Okura, Setagaya-ku, Tokyo, Japan 157-8535
TEL
03-3416-0181
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masa-aki Kumagai |
Organization
National Center for Child Health and Development
Division name
Division of Hematology
Zip code
Address
TEL
Homepage URL
kumagai-ma@ncchd.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
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 02 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
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
| 2007 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 02 | 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
| 2008 | Year | 02 | Month | 20 | Day |
Last modified on
| 2012 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001234
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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