UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058639 |
|---|---|
| Receipt number | R000067060 |
| Scientific Title | A prospective observational study of image-guided proton therapy for early-stage lung cancer |
| Date of disclosure of the study information | 2025/07/31 |
| Last modified on | 2025/07/29 20:19:14 |
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Basic information
Public title
A prospective observational study of image-guided proton therapy for early-stage lung cancer
Acronym
A prospective observational study of image-guided proton therapy for early-stage lung cancer
Scientific Title
A prospective observational study of image-guided proton therapy for early-stage lung cancer
Scientific Title:Acronym
A prospective observational study of image-guided proton therapy for early-stage lung cancer
Region
| Japan |
Condition
Condition
early-stage lung cancer
Classification by specialty
| Pneumology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To develop future treatments for early-stage lung cancer, we will conduct data registration and clinical practice (covered by insurance) as a prospective observational study in general practice, and conduct detailed analysis using our own institution's medical information.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
5 year overall survival
Key secondary outcomes
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. Patients with non-small cell lung cancer diagnosed by histology or cytology, or those with a clinical diagnosis of lung cancer
2. Patients with clinical stage IA-II diagnosed by chest and abdominal CT, head MRI, or FDG-PET within 56 days (TNM classification: 2024, UICC 9th edition).
3. Males and females aged 20 years or older at the time of obtaining consent for treatment.
4. Patients who are able to maintain a stable position during irradiation.
5. Patients who are judged to be able to plan a treatment that does not exceed the dose limits for adjacent organs.
6. Patients who are deemed suitable for proton therapy by the Cancer Board.
7. Patients who have received an explanation of the treatment using a consent form and have given written consent for treatment.
Key exclusion criteria
1. Pregnant or potentially pregnant patients
2. Patients whose wishes cannot be confirmed
3. Patients with active, refractory infections
4. Patients with psychiatric disorders or symptoms that make participation in this treatment protocol difficult
5. Patients with other serious complications (such as poorly controlled hypertension or diabetes, active gastrointestinal bleeding, etc.)
6. Patients who are deemed ineligible for this study by the researchers for medical, psychological, or other reasons other than those listed above.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Iwata |
| Middle name | |
| Last name | Hiromitsu |
Organization
Nagoya City University West Medical Center
Division name
Department of Radiation Oncology
Zip code
462-8508
Address
1-1-1 Hirate-cho, Kita-ku, Nagoya, Aichi, Japan
TEL
0529918121
h-iwa-ncu@nifty.com
Public contact
Name of contact person
| 1st name | Iwata |
| Middle name | |
| Last name | Hiromitsu |
Organization
Nagoya City University West Medical Center
Division name
Department of Radiation Oncology
Zip code
462-8508
Address
1-1-1 Hirate-cho, Kita-ku, Nagoya, Aichi, Japan
TEL
0529918121
Homepage URL
h-iwa-ncu@nifty.com
Sponsor or person
Institute
Nagoya City University West Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya City University Ethics Review Committee
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, Japan
Tel
052-858-7215
clinical_research@med.nagoya-cu.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 07 | Month | 31 | 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
| 2025 | Year | 07 | Month | 02 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 14 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 18 | Day |
Last follow-up date
| 2035 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prognosis etc.
Management information
Registered date
| 2025 | Year | 07 | Month | 29 | Day |
Last modified on
| 2025 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067060
