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
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
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
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
