UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Exploratory clinical trial of total skin irradiation for primary cutaneous lymphoma using helical TomoTherapy.
Title of the study (Brief title)	Exploratory clinical trial of total skin irradiation using helical TomoTherapy.
Region	Japan

Condition
Condition	primary cutaneous lymphoma
Classification by specialty	Hematology and clinical oncology Dermatology Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study was to elucidate the effects of total skin irradiation (TSI) for primary cutaneous lymphoma using helical TomoTherapy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The frequency of acute adverse event within three months after TSI.
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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	Device,equipment
Interventions/Control_1	Total skin irradiation using helical tomotherapy
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	a) Patients with primary cutaneous lymphoma b) Poor controled patients in the tumor phase. c) Patients with written informed consent. d) Age: 20 and older e) PS(performance status): 0-2 f) Patients accepted treatment of TSI g) WBC: 2,000/mm3 and more Platelet: 70,000/mm3 and more Hb: 10 g/dL and more GOT, GPT: less than three times the upper limit of normal T.Bil: 1.5 mg/dL or less
Key exclusion criteria	a) Patients with serious complication b) Patients who can not keep their body position c) Patients with technology problems for TSI using tomotherapy d) Patients in pregnancy and lactating woman e) Patients who are considered inadequacy for the trial
Target sample size	7

Research contact person
Name of lead principal investigator	Kae Okuma
Organization	The University of Tokyo Hospital
Division name	Department of Radiology
Address	7-3-1, Hongo Bunkyo-ku, Tokyo
TEL	03-8500-8667
Email	ookumak-rad@h.u-tokyo.ac.jp

Public contact
Name of contact person	Kae Okuma
Organization	The University of Tokyo Hospital
Division name	Department of Radiology
Address	7-3-1, Hongo Bunkyo-ku, Tokyo
TEL	03-8500-8667
Homepage URL
Email	ookumak-rad@h.u-tokyo.ac.jp

Sponsor
Institute	The University of Tokyo Hospital Department of Radiology
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	The University of Tokyo Hospital Department of Radiology
Organization
Division
Category of Funding Organization	Other
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	2016 Year 06 Month 15 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 06 Month 01 Day
Anticipated trial start date	2016 Year 06 Month 15 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

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

Management information
Registered date	2016 Year 04 Month 29 Day
Last modified on	2016 Year 04 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025516