UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048791 |
|---|---|
| Receipt number | R000055593 |
| Scientific Title | Carbon-ion radiotherapy for para-aortic lymph node metastasis |
| Date of disclosure of the study information | 2022/09/01 |
| Last modified on | 2024/09/01 18:22:40 |
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Basic information
Public title
Carbon-ion radiotherapy for para-aortic lymph node metastasis
Acronym
CIRT for PALN metastasis
Scientific Title
Carbon-ion radiotherapy for para-aortic lymph node metastasis
Scientific Title:Acronym
CIRT for PALN metastasis
Region
| Japan |
Condition
Condition
Patients who underwent carbon-ion radiotherapy for para-aortic lymph node metastasis
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To retrospectively examine the results of carbon-ion radiotherapy for para-aortic lymph node metastasis and evaluate its efficacy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
overall survival rates
Key secondary outcomes
disease-free survival rates, local control rates, acute/late toxicity rate
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
Patients who underwent carbon-ion radiotherapy to para-aortic lymph nodes from January 1, 2005 to the end of the study
Key exclusion criteria
Patients who have refused to use the data for this study by the research subject or their proxy
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Tetsuro |
| Middle name | |
| Last name | Isozaki |
Organization
National Institutes for Quantum Sciences and Technology QST Hospital
Division name
Department of radiology
Zip code
263-8555
Address
4-9-1, anagawa, inage-ku,chiba. japan
TEL
043-206-3306
isozaki.tetsuro@qst.go.jp
Public contact
Name of contact person
| 1st name | Tetsuro |
| Middle name | |
| Last name | Isozaki |
Organization
National Institutes for Quantum Sciences and Technology QST Hospital
Division name
Department of radiology
Zip code
263-8555
Address
4-9-1, anagawa, inage-ku,chiba. japan
TEL
043-206-3306
Homepage URL
isozaki.tetsuro@qst.go.jp
Sponsor or person
Institute
National Institutes for Quantum Sciences and Technology
Institute
Department
Personal name
Funding Source
Organization
National Institutes for Quantum Sciences and Technology
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
National Institutes for Quantum Sciences and Technology QST Hospital
Address
4-9-1, anagawa, inage-ku,chiba. japan
Tel
043-206-3306
isozaki.tetsuro@qst.go.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
| 2022 | Year | 09 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2005 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 12 | Day |
Anticipated trial start date
| 2005 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Data will be collected for diagnosis, age, gender, smoking history, alcohol consumption history, site of primary lesion, treatment modalities, histopathology, blood tests, prognosis, toxicities, and images such as CT, MRI, PET, and treatment planning.
Management information
Registered date
| 2022 | Year | 08 | Month | 30 | Day |
Last modified on
| 2024 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055593
