UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063011 |
|---|---|
| Receipt number | R000072044 |
| Scientific Title | A multicenter retrospective study of carbon-ion re-irradiation for locoregional recurrence, pulmonary metastasis, or secondary lung cancer after radiotherapy for primary lung cancer |
| Date of disclosure of the study information | 2026/09/24 |
| Last modified on | 2026/09/21 15:15:50 |
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Basic information
Public title
Multicenter retrospective study of carbon-ion re-irradiation for recurrent or secondary lung cancer after radiotherapy
Acronym
a study of carbon-ion re-irradiation for recurrent or secondary lung cancer
Scientific Title
A multicenter retrospective study of carbon-ion re-irradiation for locoregional recurrence, pulmonary metastasis, or secondary lung cancer after radiotherapy for primary lung cancer
Scientific Title:Acronym
Lung_reRT_carbon
Region
| Japan |
Condition
Condition
Primary lung cancer (Locoregional recurrence, pulmonary metastasis, or secondary lung cancer after radiotherapy)
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To retrospectively evaluate the safety (specifically severe radiation pneumonitis) and efficacy (overall survival, local control rate) of carbon-ion re-irradiation for recurrent or secondary lung cancer after initial radiotherapy using a multicenter registry, thereby clarifying appropriate indications.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of severe radiation pneumonitis (CTCAE Grade 2 or higher)
Key secondary outcomes
Overall survival
Recurrence free survival
Local recurrence rate accessed with death as a competing risk
Incidence and severity of adverse events worst grade based on CTCAE ver5.0
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients in the J-CROS database who have a history of X-ray or particle beam therapy for primary lung cancer.
2. Patients who underwent carbon-ion therapy between January 2016 and June 2023.
3. Cases in which carbon-ion re-irradiation (including Re-irradiation Type 1, Type 2, and Repeat Organ Irradiation) was performed for lung cancer (primary tumor enlargement, intra-lung metastasis, or regional lymph node metastasis) or synchronous or metachronous multiple lung cancers.
Key exclusion criteria
1. Cases involving only a history of radiation therapy for other cancers (such as breast cancer or esophageal cancer).
2. Cases in which particle beam therapy was administered for another cancer following particle beam therapy for lung cancer.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Nakajima |
| Middle name | |
| Last name | Mio |
Organization
National Institutes for Quantum Science and Technology, QST Hospital
Division name
Department of Radiation Oncology and Diagnostic Radiology
Zip code
263-8555
Address
4-9-1 Anagawa, Inage-ku, Chiba-shi, Chiba, Japan
TEL
043(206)3306
kokusaiml@qst.go.jp
Public contact
Name of contact person
| 1st name | Hideya |
| Middle name | |
| Last name | Yamazaki |
Organization
Osaka Heavy Ion Center
Division name
Division of Radiology
Zip code
540-0008
Address
3-1-10 Otemae, Chuo-ku, Osaka-shi, Osaka, Japan
TEL
0669473210
Homepage URL
yamahi@koto.kpu-m.ac.jp
Sponsor or person
Institute
Osaka Heavy Ion Center
Institute
Department
Personal name
Kazuhiko Hayashi
Funding Source
Organization
Self-procurement
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of QST Hospital
Address
4-9-1 Anagawa, Inage-ku, Chiba-shi, Chiba 263-8555, Japan
Tel
043(206)3306
hayashi.kazuhiko.med@osaka-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
量子科学技術研究開発機構 QST病院(千葉)
大阪重粒子線センター（大阪）
九州国際重粒子線がん治療センター（佐賀）
群馬大学医学部附属病院（群馬）
神奈川県立がんセンター（神奈川）
兵庫県立粒子線医療センター（兵庫県）
山形大学医学部
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 24 | 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
| 2026 | Year | 07 | Month | 15 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 06 | Day |
Anticipated trial start date
| 2026 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study
Management information
Registered date
| 2026 | Year | 09 | Month | 21 | Day |
Last modified on
| 2026 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072044
