UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058944 |
|---|---|
| Receipt number | R000067411 |
| Scientific Title | Prospective Multicenter Observational Study on Cardiac and Pulmonary Complications in Locally Advanced Lung Cancer Patients Treated with Carbon-Ion Radiotherapy |
| Date of disclosure of the study information | 2025/09/01 |
| Last modified on | 2025/08/31 16:24:56 |
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Basic information
Public title
Multicenter Observational Study on Cardiac and Pulmonary Complications in Advanced Lung Cancer Patients Treated with Carbon-Ion Radiotherapy
Acronym
Multicenter Study on Complications in Advanced Lung Cancer Patients Treated with CIRT
Scientific Title
Prospective Multicenter Observational Study on Cardiac and Pulmonary Complications in Locally Advanced Lung Cancer Patients Treated with Carbon-Ion Radiotherapy
Scientific Title:Acronym
LA-Lung-AR-JCROS
Region
| Japan |
Condition
Condition
Locally Advanced Lung Cancer
Classification by specialty
| Pneumology | Chest surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective is to clarify the effects of heavy-ion beam therapy on the heart, lungs, and esophagus in patients with locally advanced lung cancer by prospectively evaluating adverse events related to these organs in a multicenter study.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Adverse reaction occurring in the heart, lungs, and esophagus within 24 months after Carbon ion Radiotherapy
Key secondary outcomes
Overall survival period, local control period, and progression free survival period
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 who received carbon ion radiotherapy for locally advanced lung cancer between September 1, 2025, and March 31, 2028
Key exclusion criteria
If the research subject or their representative refuses the use of their data for this research
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hitoshi |
| Middle name | |
| Last name | Isihkawa |
Organization
QST Hospital, National Institute for Quantum and Radiological Sciences and Technology
Division name
Department of Diagnostic Radiology and Radiation Oncology
Zip code
2638555
Address
4-9-1 Anagawa, Inage-ku, Chiba-shi, Chiba, Japan
TEL
0432063306
Ishikawa.hitoshi@qst.go.jp
Public contact
Name of contact person
| 1st name | Mio |
| Middle name | |
| Last name | Nakajima |
Organization
QST Hospital, National Institute for Quantum and Radiological Sciences and Technology
Division name
Department of Diagnostic Radiology and Radiation Oncology
Zip code
2638555
Address
4-9-1 Anagawa, Inage-ku, Chiba-shi, Chiba, Japan
TEL
0432063306
Homepage URL
nakajima.mio@qst.go.jp
Sponsor or person
Institute
National Institutes for Quantum Science and Technology
Institute
Department
Personal name
Mio Nakajima
Funding Source
Organization
National Institutes for Quantum Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
QST Hospital, National Institute for Quantum and Radiological Sciences and Technology
Address
4-9-1 Anagawa, Inage-ku, Chiba-shi, Chiba, Japan
Tel
0432063306
helsinki@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
| 2025 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 07 | Month | 22 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 27 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The objective of this study is to evaluate adverse reactions to heart, lung, and esophagus in Carbon ion radiotherapy (CIRT) for locally advanced lung cancer through a multicenter, prospective assessment, thereby clarifying the effects of CIRT on the heart, lungs, and esophagus in locally advanced lung cancer. CIRT in Japan is conducted by the Japanese Consortium for Carbon Ion Radiation Therapy (J-CROS). As part of its activities under the National Registration and Clinical Evaluation of CIRT cases, J-CROS has been collecting treatment data (J-CROS data) for all patients who underwent CIRT at domestic facilities into a dedicated database since May 2016. The JCROS data is managed at a data center established within QST Hospital. Applications for its use are accepted based on the rules governing its utilization (J-CROS Data Usage Rules). This study will perform analyses using this J-CROS data.
Management information
Registered date
| 2025 | Year | 08 | Month | 31 | Day |
Last modified on
| 2025 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067411
