UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022142
Receipt number R000025516
Scientific Title Exploratory clinical trial of total skin irradiation for primary cutaneous lymphoma using helical TomoTherapy.
Date of disclosure of the study information 2016/06/15
Last modified on 2016/04/29 19:56:42

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Basic information

Public title

Exploratory clinical trial of total skin irradiation for primary cutaneous lymphoma using helical TomoTherapy.

Acronym

Exploratory clinical trial of total skin irradiation using helical TomoTherapy.

Scientific Title

Exploratory clinical trial of total skin irradiation for primary cutaneous lymphoma using helical TomoTherapy.

Scientific Title:Acronym

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



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



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

1st name
Middle name
Last name Kae Okuma

Organization

The University of Tokyo Hospital

Division name

Department of Radiology

Zip code


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

1st name
Middle name
Last name Kae Okuma

Organization

The University of Tokyo Hospital

Division name

Department of Radiology

Zip code


Address

7-3-1, Hongo Bunkyo-ku, Tokyo

TEL

03-8500-8667

Homepage URL


Email

ookumak-rad@h.u-tokyo.ac.jp


Sponsor or person

Institute

The University of Tokyo Hospital
Department of Radiology

Institute

Department

Personal name



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)



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

2016 Year 06 Month 15 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

2016 Year 06 Month 01 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025516


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name