UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A pilot study on total body irradiation using TomoTherapy IMRT prior to hematopoietic stem cell transplantation
Title of the study (Brief title)	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	Katsuyuki Karasawa
Organization	Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Division name	Dept. of Radiology
Address	3-18-22, Honkomagome, Bunkyo-ku Tokyo
TEL	03-3823-2101
Email	karasawa@cick.jp

Public contact
Name of contact person	Kazuteru Ohashi
Organization	Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Division name	Hematology Division
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 06 Month 11 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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