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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000017517
Receipt No. 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 2021/05/18

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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
Email 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
Email ksasai@juntendo.ac.jp

Sponsor
Institute Juntendo Unicersity, Graduate School of Medicine, Department of Radiation Oncology
Institute
Department

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
Email 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
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 No longer recruiting
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
2021 Year 05 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020129

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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