UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033248 |
|---|---|
| Receipt number | 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 20:56:49 |
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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
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
k.ohashi@cick.jp
Sponsor or person
Institute
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037906
