UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000973 |
|---|---|
| Receipt number | R000001097 |
| Scientific Title | An early phase II study of delayed local treatment with surgery and radiation, that follows high dose chemotherapy with peripheral blood stem cell transplantation in patients with advanced neuroblastoma |
| Date of disclosure of the study information | 2008/01/07 |
| Last modified on | 2012/02/07 09:51:51 |
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Basic information
Public title
An early phase II study of delayed local treatment with surgery and radiation, that follows high dose chemotherapy with peripheral blood stem cell transplantation in patients with advanced neuroblastoma
Acronym
An early phase II study of delayed local treatment in advanced neuroblastoma
Scientific Title
An early phase II study of delayed local treatment with surgery and radiation, that follows high dose chemotherapy with peripheral blood stem cell transplantation in patients with advanced neuroblastoma
Scientific Title:Acronym
An early phase II study of delayed local treatment in 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 examine the efficacy and toxicity of delayed local treatment with surgery and radiation, that follows bone marrow ablative high-dose chemotherapy and autologous hematopoietic stem cell transplantation, in children older than 1 year with INSS stage 4 neuroblastoma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
1-year progression-free survival rate from the 12th week of the protocol
Key secondary outcomes
2-year progression-free and overall survival rates, clinical response rate at the 12th week of the protocol and that before surgery, 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
Chemothrapy, surgery and radiation in INSS satge 4 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
Childen older than 1 year with INSS stage 4 neuroblastoma
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
16
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideo Mugishima |
Organization
Nihon University School Of Medicine
Division name
Division of Pediatrics and Child Health
Zip code
Address
30-1,Oyaguchi-kamichou,Itabashiku,Tokyou,Japan
TEL
03-3972-8111(2442)
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Shichino |
Organization
Nihon University School Of Medicine
Division name
Division of Pediatrics and Child Health
Zip code
Address
30-1,Oyaguchi-kamichou,Itabashiku,Tokyou,Japan
TEL
0339728111(2442)
Homepage URL
http://www.jnbsg.jp/
shichino.hiroyuki@nihon-u.ac.jp
Sponsor or person
Institute
Japan Neuroblastoma Study Group
Institute
Department
Personal name
Funding Source
Organization
A research grant from the Ministry of Health, Labour and Welfare: Cancer clinical research project of the year 2009
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 | 01 | Month | 07 | Day |
Related information
URL releasing protocol
http://www.jnbsg.jp/
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Background: The progression-free survival rates of high risk neuroblastoma (HR-NB) patients are still unacceptable. The Japan Neuroblastoma Study Group (JNBSG) has examined the feasibility of time-intensive multimodal treatment with delayed local control treatment (DLCT).
Methods: Between June 2006 and February 2008, 11 patients, four male and seven female, with newly diagnosed HR-NB patients were enrolled in the study. The median age at diagnosis was 22 months (range, 13 to 66 months). DLCT consisted of induction chemotherapy (IC) with cisplatin (100mg/m2), pirarubicin (40mg/m2), vincristine (1.5mg/m2), and cyclophosphamide (2,400mg/m2). After 5 courses of IC, all patients were treated immediately with myeloablative chemotherapy with carboplatin (1,600mg/m2), etoposide (800mg/m2), and melphalan (200mg/m2). After these treatments, local tumor eradication with surgery and irradiation (21Gy) was performed.
Results: DLCT was completed in 4 patients, while it was discontinued in the remaining 7 patients due to progressive disease (PD) or regimen related toxicity (RRT). Six patients died due to PD (n=4) or RRT (n=2), and 5 patients were alive at the time of evaluation.
Conclusions: These results suggest that DLCT is feasible in terms of completion. Based on the results of the study, we designed a phase II study that will be conducted by the JNBSG.
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
| 2005 | Year | 11 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2009 | 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
| 2008 | Year | 01 | Month | 07 | Day |
Last modified on
| 2012 | Year | 02 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001097
