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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033248
Receipt No. R000037906
Scientific Title A pilot study on total body irradiation using TomoTherapy IMRT prior to hematopoietic stem cell transplantation
Date of disclosure of the study information 2018/07/03
Last modified on 2018/07/02

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Basic information
Public title A pilot study on total body irradiation using TomoTherapy IMRT prior to hematopoietic stem cell transplantation
Acronym TomoTBI
Scientific Title A pilot study on total body irradiation using TomoTherapy IMRT prior to hematopoietic stem cell transplantation
Scientific Title:Acronym TomoTBI
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the safety of total body irradiation using TomoTherapy IMRT prior to allogeneic hematopoietic stem cell transplantation.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Frequency of Grade 3 or greater adverse events 3 months to 1 year following total body irradiation.
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
Device,equipment
Interventions/Control_1 Irradiation using TomoTherapy Radixact
Total Body Irradiation with 2Gy/fr, twice a day, 3 consecutive days 12Gy/6fr in total. At least 6 hours interval between the treatment.
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
60 years-old >
Gender Male and Female
Key inclusion criteria 1. Patient with hematopoietic malignancy who is scheduled to receive myeloablative conditioning using Total Body Irradiation (12Gy/6fr) for allogeneic stem cell transplantation
2. ECOG PS 0-2
3. Written informed consent
Key exclusion criteria 1. General condition unfit for Total Body Irradiation 28days prior to registration.
2. Patient with active disease
3. Active other cancers
4. Unable to tolerate fixation during Total Body Irradiation
5. Unfit for TomoTherapy irradiation due to technical reasons
6. Patient during pregnancy
7. History of allogeneic or autologous transplantation
8. Other cases in which investigators considered unfit for this study
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Katsuyuki Karasawa
Organization Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Division name Dept. of Radiology
Zip code
Address 3-18-22, Honkomagome, Bunkyo-ku Tokyo
TEL 03-3823-2101
Email karasawa@cick.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuteru Ohashi
Organization Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Division name Hematology Division
Zip code
Address 3-18-22, Honkomagome, Bunkyo-ku Tokyo
TEL 03-3823-2101
Homepage URL
Email k.ohashi@cick.jp

Sponsor
Institute Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Local Government
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

Other administrative information
Date of disclosure of the study information
2018 Year 07 Month 03 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 Preinitiation
Date of protocol fixation
2018 Year 06 Month 11 Day
Date of IRB
Anticipated trial start date
2018 Year 07 Month 03 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 07 Month 02 Day
Last modified on
2018 Year 07 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037906

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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