UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062261 |
|---|---|
| Receipt number | R000071246 |
| Scientific Title | A nationwide prospective observational study of high-precision hypofractionated radiation therapy for centrally located non-small cell lung cancer with tumor diameter less than 3cm without metastasis |
| Date of disclosure of the study information | 2026/07/21 |
| Last modified on | 2026/07/16 22:04:07 |
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Basic information
Public title
A nationwide prospective observational study of high-precision hypofractionated radiation therapy for centrally located non-small cell lung cancer with tumor diameter less than 3cm without metastasis
Acronym
JROSG19-1
Scientific Title
A nationwide prospective observational study of high-precision hypofractionated radiation therapy for centrally located non-small cell lung cancer with tumor diameter less than 3cm without metastasis
Scientific Title:Acronym
JROSG19-1
Region
| Japan |
Condition
Condition
non-small cell lung cancer
Classification by specialty
| Pneumology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We will conduct a multicenter, prospective registry of patient data on high-precision, hypofractionated radiation therapy for centrally located non-small cell lung cancer with tumor diameter less than 3cm without metastasis in Japan, in order to assess the actual treatment outcomes and adverse events.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
3-Year Overall Survival Rate
Key secondary outcomes
Grade 5 Adverse Event Incidence Rate
3-Year Local Progression-Free Survival Rate
Pattern of Progression
Acute Adverse Event Incidence Rate
Late Adverse Event Incidence 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Meet either criterion 1. or 2. below.
1. Pathologically confirmed non-small cell lung cancer
2. Meet criteria a) through d) below and have been clinically diagnosed with primary non-small cell lung cancer.
a) An increase in tumor size of 1 mm or more is observed on chest CT scans performed at least twice at intervals of 28 days or more
b) There is clear abnormal uptake on FDG-PET.
c) NSE and Pro-GRP levels, as measured within 28 days prior to enrollment, are within the institution's reference range.
d) No tumor-associated syndromes (SIADH, ectopic ACTH syndrome, Lambert-Eaton syndrome) are present.
2) Located within 2 cm of central structures (trachea, bronchi (up to the second-order branches), major blood vessels, esophagus, heart, brachial plexus, or spinal cord); eligibility is met if even a portion of the tumor is within this range (including ground-glass opacities).
3) Based on contrast-enhanced chest and abdominal CT performed within 56 days prior to enrollment, as well as FDG-PET and contrast-enhanced head MRI performed within 84 days prior to enrollment, the total diameter of the lesion must be 3 cm or less, and there must be no evidence of lymph node or distant metastases (cases diagnosed by staging using non-contrast CT or MRI when contrast-enhanced imaging is not feasible, or head CT when MRI is not feasible, are also eligible).
4) Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) is 0-2.
5) Age is 20 years or older.
6) High-precision irradiation (position reproducibility of the irradiation center within 5 mm for each fraction) is planned.
7) Meets the criteria for one of the three standard dose fractionation schemes and dose constraints.
8) Treatment is planned using a standard dose fractionation scheme and dose constraints that meet the criteria.
Key exclusion criteria
1) Concurrent or sequential combination drug therapy for the underlying condition is planned.
2) The patient has a severe mental illness.
3) The attending physician deems the patient unsuitable for participation in this study for other reasons.
Target sample size
81
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Onishi |
Organization
University of Yamanashi Faculty of Medicine
Division name
Department of therapeutic radiology
Zip code
4093898
Address
1110, Shimokato, Chuo,Yamanashi, 409-3898 Japan
TEL
81-55-273-9579
honishi@yamanashi.ac.jp
Public contact
Name of contact person
| 1st name | Takafumi |
| Middle name | |
| Last name | Komiyama |
Organization
University of Yamanashi Faculty of Medicine
Division name
Department of therapeutic radiology
Zip code
4093898
Address
1110, Shimokato, Chuo,Yamanashi, 409-3898 Japan
TEL
81-55-273-9579
Homepage URL
https://jrosg.or.jp/%e4%b8%80%e8%88%ac%e3%81%ae%e7%9a%86%e6%a7%98%e3%81%b8/jrosg-24-1-2/
takafumi@yamanashi.ac.jp
Sponsor or person
Institute
Japan Radiation Oncology Study Group
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Yamanashi Ethics committee
Address
1110, Shimokato, Chuo,Yamanashi, 409-3898 Japan
Tel
81-55-273-1111
rec-med@yamanashi.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
JROSG19-1
Org. issuing International ID_1
Japan Radiation Oncology Study Group
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 21 | 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
| 2024 | Year | 12 | Month | 24 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 24 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 14 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study includes both 3D-CRT and IMRT treatment planning methods.
1. 42 Gy in 4 fraction
2. 50 Gy in 8 fraction
3. 62.5 Gy in 25 fraction
Management information
Registered date
| 2026 | Year | 07 | Month | 16 | Day |
Last modified on
| 2026 | Year | 07 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071246
