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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000004969
Receipt No. R000005517
Scientific Title Total body irradiation, cyclophosphamide and imported Tiotepa for conditioning chemotherapy of pediatric refractory malignancy
Date of disclosure of the study information 2011/02/14
Last modified on 2011/01/27

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Basic information
Public title Total body irradiation, cyclophosphamide and imported Tiotepa for conditioning chemotherapy of pediatric refractory malignancy
Acronym Total body irradiation, cyclophosphamide and imported Tiotepa
Scientific Title Total body irradiation, cyclophosphamide and imported Tiotepa for conditioning chemotherapy of pediatric refractory malignancy
Scientific Title:Acronym Total body irradiation, cyclophosphamide and imported Tiotepa
Region
Japan

Condition
Condition pediatric with refractory malignancy
Classification by specialty
Pediatrics
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 establish the safety of imported thiotepa in the treatment
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes safty of treatment
Key secondary outcomes curative effect

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 imported Thiotepa
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
20 years-old >=
Gender Male and Female
Key inclusion criteria not poor general condition with malignancy
Key exclusion criteria poor general condition with malignancy
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kato Hiromi
Organization YOKOHAMA CITY UNIVERSITY SCHOOL OF MEDICINE
Division name PEDIATRICS
Zip code
Address 3-9 FUKUURA,KANAZAWA-KU YOKOHAMA 236-0004 JAPAN
TEL 045-787-2800
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kato Hiromi
Organization YOKOHAMA CITY UNIVERSITY SCHOOL OF MEDICINE
Division name PEDIATRICS
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute YOKOHAMA CITY UNIVERSITY SCHOOL OF MEDICINE
Institute
Department

Funding Source
Organization YOKOHAMA CITY UNIVERSITY SCHOOL OF MEDICINE
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 横浜市立大学附属病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2011 Year 02 Month 14 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 Enrolling by invitation
Date of protocol fixation
2011 Year 02 Month 14 Day
Date of IRB
Anticipated trial start date
2011 Year 02 Month 01 Day
Last follow-up date
2013 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
2011 Year 01 Month 27 Day
Last modified on
2011 Year 01 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005517

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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