UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061387 |
|---|---|
| Receipt number | R000070237 |
| Scientific Title | A Prospective Interventional Study to Evaluate Changes in Pulmonary Function Following Carbon-Ion Radiotherapy for Lung Tumors |
| Date of disclosure of the study information | 2026/04/27 |
| Last modified on | 2026/04/27 14:04:01 |
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Basic information
Public title
A prospective interventional study evaluating changes in pulmonary function following carbon-ion radiotherapy for lung tumors
Acronym
Pulmonary function after carbon-ion radiotherapy for lung tumors
Scientific Title
A Prospective Interventional Study to Evaluate Changes in Pulmonary Function Following Carbon-Ion Radiotherapy for Lung Tumors
Scientific Title:Acronym
Prospective study of pulmonary function afafte carbon-ion radiotherapy for lung tumors
Region
| Japan |
Condition
Condition
Patients receiving carbon-ion radiotherapy for primary lung cancer or metastatic lung tumors
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To prospectively evaluate pulmonary function in patients with primary lung cancer or metastatic lung tumors treated with carbon-ion radiotherapy, and to analyze the impact of the treatment on respiratory function and its association with follow-up data, including post-treatment adverse events.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Absolute and percentage changes in pulmonary function before and after carbon-ion radiotherapy
Key secondary outcomes
Association between changes in pulmonary function and factors including the occurrence of adverse events and dosimetric parameters
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Pulmonary function tests at approximately 3, 6, and 12 months after carbon-ion radiotherapy
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 scheduled to undergo carbon-ion radiotherapy for primary lung cancer or metastatic lung tumors between the date of institutional approval and December 31, 2029, OR patients who have provided consent for the existing study at our institution (N25-013: A prospective observational study evaluating changes in pulmonary function following carbon-ion radiotherapy for lung tumors), provided they are capable of giving written informed consent for this study.
2. Patients aged 18 years or older at the time of informed consent (regardless of gender).
3. Patients who are scheduled to visit our institution for follow-up for at least 1 year after the completion of treatment.
4. Patients judged by an investigator or attending physician to be capable of understanding the informed consent document.
Key exclusion criteria
Patients judged by an investigator or attending physician to be ineligible for this study
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Ryo |
| Middle name | |
| Last name | Karita |
Organization
National Institutes for Quantum Science and Technology QST hospital
Division name
Section of Head, Neck and Thoracic Tumors, Department of Treatment and Diagnosis
Zip code
263-8555
Address
4-9-1 Anagawa, Inage-ku, Chiba-shi, Chiba
TEL
043-206-3306
karita.ryo@qst.go.jp
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Karita |
Organization
National Institutes for Quantum Science and Technology QST hospital
Division name
Section of Head, Neck and Thoracic Tumors, Department of Treatment and Diagnosis
Zip code
263-8555
Address
4-9-1 Anagawa, Inage-ku, Chiba-shi, Chiba
TEL
043-206-3306
Homepage URL
karita.ryo@qst.go.jp
Sponsor or person
Institute
National Institutes for Quantum Science and Technology QST hospital
Institute
Department
Personal name
Funding Source
Organization
National Institutes for Quantum Science and Technology QST hospital
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 Science and Technology Institutional Review Board
Address
4-9-1 Anagawa, Inage-ku, Chiba-shi, Chiba
Tel
043-382-3703
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
国立研究開発法人量子科学技術研究開発機構QST病院
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 27 | 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 | 03 | Month | 18 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 27 | Day |
Anticipated trial start date
| 2026 | Year | 05 | Month | 04 | Day |
Last follow-up date
| 2030 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2030 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2031 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2026 | Year | 04 | Month | 27 | Day |
Last modified on
| 2026 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070237
