UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017517 |
|---|---|
| Receipt number | R000020129 |
| Scientific Title | Phase I and II trial of lens block during electron radiation therapy for low grade lymphoma arising from conjunctiva |
| Date of disclosure of the study information | 2015/05/12 |
| Last modified on | 2022/02/25 11:15:16 |
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Basic information
Public title
Phase I and II trial of lens block during electron radiation therapy for low grade lymphoma arising from conjunctiva
Acronym
Phase I and II trial of lens block
Scientific Title
Phase I and II trial of lens block during electron radiation therapy for low grade lymphoma arising from conjunctiva
Scientific Title:Acronym
Phase I and II trial of lens block
Region
| Japan |
Condition
Condition
Low grade malignant lymphoma arising from conjunctiva
Classification by specialty
| Hematology and clinical oncology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To confirm the safety and efficacy of newly developed lens block during electron radiation therapy for low grade malignant lymphoma arising from conjunctiva
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Adverse effects of lens block
Key secondary outcomes
1 Radiation effects for the lymphomas
a local control rate
b overall survival
c progression free survival
2 Frequency of cataracts after the treatment
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
Before use of the block, ipsilateral cornea and conjunctiva receive local anesthesia.
After the locations of the block, the conjunctiva is irradiated 2Gy with electron beam in one session.
Patients usually receive such treatment 13-15 times during 3 weeks.
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
1. 20 years old or older
2. Localized low-grade lymphoma arising from conjunctiva
3. It is supposed that the use of lens-bock is effective.
4. Consent from the patient for participating in the study is obtained.
Key exclusion criteria
1. Retro-bulbar lesion
2. Allergy for local anesthesia
3. History of lens exchange
4. Infectious diseases or other disorders of the eye
5. Patients who are determined inadequate for the use the lens block from the viewpoint of the main investigator
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Keisuke |
| Middle name | |
| Last name | Sasai |
Organization
Juntendo University
Division name
Department of Radiation Onclogy
Zip code
113-8431
Address
2-1-1 Hongo, Bunkyo, Tokyo
TEL
3-3813-3111
ksasai@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | keisuke |
| Middle name | |
| Last name | Sasai |
Organization
Juntendo University
Division name
Department of Radiation Onclogy
Zip code
113-8431
Address
2-1-1 Hongo, Bunkyo, Tokyo
TEL
3-3813-3111
Homepage URL
http://www.juntendo.ac.jp/hospital/index.php
ksasai@juntendo.ac.jp
Sponsor or person
Institute
Juntendo Unicersity, Graduate School of Medicine, Department of Radiation Oncology
Institute
Department
Personal name
Funding Source
Organization
Juntendo University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hospital Ethics Committee, Juntendo University Hospital
Address
3-1-3 Hongo, Bunkyo
Tel
0338133111
jun-rinri@juntendo.ac.jp
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
順天堂大学医学部附属順天堂医院（東京都）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 12 | 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
3
Results
Due to the low number of patients enrolled, we cannot reach any meaningful conclusions. However, no one of the three patients has experienced any symptoms related to cataract.
Results date posted
| 2022 | Year | 02 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
No significant adverse events related to the lens block were observed.
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2015 | Year | 04 | Month | 28 | Day |
Date of IRB
| 2015 | Year | 04 | Month | 30 | Day |
Anticipated trial start date
| 2015 | Year | 05 | Month | 12 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 25 | Day |
Date of closure to data entry
| 2023 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 12 | Day |
Last modified on
| 2022 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020129
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