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

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 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


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

Value
https://center6.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