UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052389 |
|---|---|
| Receipt number | R000059804 |
| Scientific Title | A retrospective study to evaluate the efficacy and safety of carbon ion radiation therapy for primary lung cancer. |
| Date of disclosure of the study information | 2023/10/03 |
| Last modified on | 2023/10/03 13:45:55 |
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Basic information
Public title
A retrospective study to evaluate the efficacy and safety of carbon ion radiation therapy for primary lung cancer.
Acronym
A retrospective study of carbon ion radiation therapy for primary lung cancer
Scientific Title
A retrospective study to evaluate the efficacy and safety of carbon ion radiation therapy for primary lung cancer.
Scientific Title:Acronym
A retrospective study of carbon ion radiation therapy for primary lung cancer
Region
| Japan |
Condition
Condition
primary lung cancer
Classification by specialty
| Pneumology | Chest surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of carbon ion radiation therapy in primary lung cancer patients treated at QST Hospital, and to conduct a retrospective analysis of prognostic predictors and criteria for treatment eligibility.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
Adverse events, local control, recurrence-free survival, respiratory function preservation 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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients treated with carbon ion radiation therapy for primary lung cancer at QST Hospital from April 1994 to March 2025
Key exclusion criteria
Refusal by the patient
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Shuri |
| Middle name | |
| Last name | Aoki |
Organization
National institutes for Quatum Science and Technology QST Hospital
Division name
National institutes for Quatum Science and Technology QST Hospital
Zip code
263-8555
Address
4-9-1 Anagawa, Inage-ku, Chiba-shi, Chiba 263-8555, Japan
TEL
0432063306
aoki.shuri@qst.go.jp
Public contact
Name of contact person
| 1st name | Shuri |
| Middle name | |
| Last name | Aoki |
Organization
National institutes for Quatum Science and Technology QST Hospital
Division name
Division of Treatment and Diagnosis
Zip code
263-8555
Address
4-9-1 Anagawa, Inage-ku, Chiba-shi, Chiba 263-8555, Japan
TEL
0432063306
Homepage URL
https://www.nirs.qst.go.jp/research/review/document/optout/Optout_N22-023.pdf
aoki.shuri@qst.go.jp
Sponsor or person
Institute
National institutes for Quatum Science and Technology
Institute
Department
Personal name
Funding Source
Organization
National institutes for Quatum Science 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 Quatum Science and Technology QST Hospital
Address
4-9-1 Anagawa, Inage-ku, Chiba-shi, Chiba 263-8555, Japan
Tel
0432063306
aoki.shuri@qst.go.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
N22-023
Org. issuing International ID_1
National institutes for Quatum Science and Technology QST Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 10 | Month | 03 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 02 | Month | 28 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 28 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 09 | 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
None
Management information
Registered date
| 2023 | Year | 10 | Month | 03 | Day |
Last modified on
| 2023 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059804
