UMIN-CTR Clinical Trial

Basic information
Public title	Targeted radiotherapy for chemotherapy resistant neuroblastoma with I-131 metaiodobenzylguanidine (MIBG)
Acronym	Targeted radiotherapy for chemotherapy resistant neuroblastoma with MIBG
Scientific Title	Targeted radiotherapy for chemotherapy resistant neuroblastoma with I-131 metaiodobenzylguanidine (MIBG)
Scientific Title:Acronym	Targeted radiotherapy for chemotherapy resistant neuroblastoma with MIBG
Region	Japan

Condition
Condition	neuroblastoma
Classification by specialty	Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To observe therapeutic efficacy and toxicity of standard dose and high dose MIBG therapy in chemotherapy resistant neuroblasttoma
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1)assessment of anti-tumor effects with tumor size and tumor markers 2)assessment of prognosis 3)assessment of symptoms
Key secondary outcomes

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	targeted radiotherapy
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1)patients with histologically proven neuroblastoma 2)positive I131-MIBg uptake 3)patients with written informed consent from parents 4)patients with ADL adequate for treatment in an isolation room. patients with limited ADL which can be compensated by the others under the approval of the ethical board 5)in case that high-dose treatment is chosen, bone marrow support must be secured.
Key exclusion criteria	1)patients with disturbed consciousness 2)expected life span less than 1 month 3)limited bone marrow capacity Hb<9.0, WBC count<3,000, platelet count <100,000 4)renal disorder GFR<30 ml/min/1.73 m2 5)risks for the central nerve system during treatment 6)in case that radiation safety cannot be secured. in case with uncontrolled symptoms that may require emergent medical cares. in case that understanding and cooperation cannot be obtained from family members. 7) when medical staff determine that treatment cannot be properly carried out.
Target sample size	90

Research contact person
Last name of lead principal investigator	1st name Seigo Middle name Last name Kinuya
Organization	Kanazawa university Hospital
Division name	Department of Nuclear Medicine
Zip code	920-8641
Address	13-1 Takaramachi, Kanazawa, Ishikawa
TEL	076-265-2333
Email	kinuya@med.kanazawa-u.ac.jp

Public contact
1st name of contact person	1st name Seigo Middle name Last name Kinuya
Organization	Kanazawa University Hospital
Division name	Department of Nuclear Medicine
Zip code	920-8641
Address	13-1 Takaramachi, Kanazawa, Ishikawa
TEL	076-265-2333
Homepage URL
Email	kinuya@med.kanazawa-u.ac.jp

Sponsor
Institute	Kanazawa University Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Innovative Clinical Research Center, Kanazawa University
Address	13-1, Takara-machi, Kanazawa
Tel	076-265-2090
Email	crc.irb-knz@esct.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

Other administrative information
Date of disclosure of the study information	2009 Year 09 Month 18 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	Terminated
Date of protocol fixation	2009 Year 09 Month 10 Day
Date of IRB	2009 Year 09 Month 11 Day
Anticipated trial start date	2009 Year 09 Month 11 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2009 Year 09 Month 18 Day
Last modified on	2019 Year 05 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003090