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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000017563
Receipt No. R000020341
Scientific Title Intensity-modulated radiation therapy for total body irradiation in hematopoietic stem cell transplantation: Phase II study
Date of disclosure of the study information 2015/05/14
Last modified on 2020/05/17

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Basic information
Public title Intensity-modulated radiation therapy for total body irradiation in hematopoietic stem cell transplantation: Phase II study
Acronym IMRT-TBI study
Scientific Title Intensity-modulated radiation therapy for total body irradiation in hematopoietic stem cell transplantation: Phase II study
Scientific Title:Acronym IMRT-TBI study
Region
Japan

Condition
Condition hematopoietic malignancy
Classification by specialty
Hematology and clinical oncology Pediatrics Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess safety and efficacy of total body irradiation by intensity-modulated radiation therapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Frequency of grade 3 or worse adverse events, based on CTCAE ver. 4.0, from 3 months to 1 year after total body irradiation.
Key secondary outcomes Reccurence-free survial, overall survival, graft survival rate, time to graft survival, and frequency of grade 3 or worse adverse events in full observation period.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 In our institution, total body irradiation are performed as preparative regimen for hematopoietic stem cell transplantation by intensity-modulated radiation therapy.
Prescribed dose is 12 Gy in 6 fractions in 3 days. Dose to lung is reduced under 10 Gy.
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

Not applicable
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria Undergoing hematopoietic stem cell transplantation by myeloablative preparation.
Performance status is from 0 to 2.
With informed consent. If the patient is underage, we obtain informed consent from parent or legal representation.
Key exclusion criteria With serious complication.
With simultaneous double cancer or heterochronic double cancer in last 5 years.
With previous history of radiation.
Not being able to remain at rest during treatment.
With technical problem for intensity-modulated radiation therapy.
Being in pregnancy.
Judging inadequate by any medical, psychological or other reasons.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Hideomi
Middle name
Last name YAMASHITA
Organization The University of Tokyo Hospital
Division name The department of Radiology
Zip code 113-8655
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL +81-3-5800-8667
Email yamachan07291973@yahoo.co.jp

Public contact
Name of contact person
1st name Ryosuke
Middle name
Last name TAKENAKA
Organization The University of Tokyo Hospital
Division name The department of Radiology
Zip code 113-8655
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL +81-3-5800-8667
Homepage URL
Email rtakenaka-tky@umin.ac.jp

Sponsor
Institute The University of Tokyo 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 The University of Tokyo Hospital
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo
Tel 03-5800-5411
Email IRBjimu-tokyo@umin.ac.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 東京大学医学部附属病院(東京都)

Other administrative information
Date of disclosure of the study information
2015 Year 05 Month 14 Day

Related information
URL releasing protocol http://www.u-tokyo-rad.jp/data/IMRT-TBIprotocol.pdf
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 50
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 No longer recruiting
Date of protocol fixation
2015 Year 05 Month 13 Day
Date of IRB
2015 Year 05 Month 13 Day
Anticipated trial start date
2015 Year 05 Month 13 Day
Last follow-up date
2021 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
2015 Year 05 Month 14 Day
Last modified on
2020 Year 05 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020341

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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