UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040548 |
|---|---|
| Receipt number | R000045445 |
| Scientific Title | Retrospective analysis of hyper-fractionated radiotherapy for LD-SCLC |
| Date of disclosure of the study information | 2020/05/31 |
| Last modified on | 2020/05/27 16:42:52 |
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Basic information
Public title
Retrospective analysis of hyper-fractionated radiotherapy for LD-SCLC
Acronym
Hyper-fractionated radiotherapy for LD-SCLC
Scientific Title
Retrospective analysis of hyper-fractionated radiotherapy for LD-SCLC
Scientific Title:Acronym
Restrospective analysis of HFRT for LD-SCLC
Region
| Japan |
Condition
Condition
Small cell lung carcinoma
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of chemo-radiotherapy using hyper-fractionated radiotherapy for small cell lung carcinoma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
Local control
Late toxicity
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Diagnosed as limited disease of small cell lung carcinoma.
2) Case of chemo-radiotherapy using hyper-fractionated radiotherapy.
Key exclusion criteria
Case of radiotherapy for recurrence.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Nemoto |
Organization
Faculty of Medicine, Yamagata University
Division name
Division of Radiation Oncology
Zip code
990-9585
Address
2-2-2 Iida-nishi, Yamagata, Japan
TEL
+81-23-628-5386
knemoto@ymail.plala.or.jp
Public contact
Name of contact person
| 1st name | Yasuhito |
| Middle name | |
| Last name | Hagiwara |
Organization
Faculty of Medicine, Yamagata University
Division name
Division of Radiation Oncology
Zip code
990-9585
Address
2-2-2 Iida-nishi, Yamagata, Japan
TEL
+81-23-628-5386
Homepage URL
hagiwara.yasuhito@gmail.com
Sponsor or person
Institute
Faculty of Medicine, Yamagata University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Ethical Review Committee of Yamagata University Faculty of Medicine
Address
2-2-2 Iida-nishi, Yamagata, Japan
Tel
+81-23-628-5047
ikekenkyu@jm.kj.yamagata-u.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 05 | Month | 31 | 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
38
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
Completed
Date of protocol fixation
| 2015 | Year | 11 | Month | 10 | Day |
Date of IRB
| 2015 | Year | 11 | Month | 10 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 10 | Day |
Last follow-up date
| 2020 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2020 | Year | 05 | Month | 27 | Day |
Last modified on
| 2020 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045445
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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