UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058065 |
|---|---|
| Receipt number | R000066366 |
| Scientific Title | Clinical trial of four-fraction proton beam irradiation for peripheral stage I-IIA lung cancer |
| Date of disclosure of the study information | 2025/06/16 |
| Last modified on | 2025/06/03 12:20:27 |
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Basic information
Public title
Clinical trial of four-fraction proton beam therapy for localized and peripheral lung cancer
Acronym
Four-fraction proton beam therapy for lung cancer
Scientific Title
Clinical trial of four-fraction proton beam irradiation for peripheral stage I-IIA lung cancer
Scientific Title:Acronym
Four-fraction proton beam irradiation for peripheral lung cancer
Region
| Japan |
Condition
Condition
Lung cancer
Classification by specialty
| Pneumology | Chest surgery | Radiology |
| Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of proton beam therapy using a four-fraction method for peripheral lung cancer cT1a-2bN0M0.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
3-year survival rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Four-fraction proton beam therapy
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 who have been histologically diagnosed with lung cancer or who have been clinically diagnosed with lung cancer and who meet any of the following criteria
a) Chest CT scans performed at least twice at intervals of 28 days or more meet any of the following criteria:
Tumor diameter (regardless of whether it is the longest diameter or not) increases by 1 mm or more
Consolidation to tumor ratio (C/T ratio) was 50% or more, but has changed to C/T ratio >50%
Note: The above findings, whether contrast or plain, can be confirmed at any time before registration.
b) FDG-PET shows obvious abnormal accumulation.
(2) Patients with T1a-T2bN0M0 according to the 9th UICC/TNM classification
(3) Performance status (PS) (European Organization for Research and Treatment of Cancer [ECOG]): 0-2
(4) Patients aged 20 years or older
(5) Patients who can maintain a proper position during irradiation
(6) Patients for whom proton beam therapy is technically feasible
(7) Patients who have been given written explanations and have given written informed consent
Key exclusion criteria
Patients who meet any of the following criteria will be excluded.
(1) Tumors within 2 cm of the trachea, main bronchus, or lobar bronchus
(2) Patients with interstitial pneumonia
(3) Patients who have previously undergone radiotherapy in the area to be irradiated
(4) Patients with active and refractory infections
(5) Patients with serious complications
(6) Patients with active secondary cancers
Note: Lesions equivalent to carcinoma in situ in the esophagus, stomach, colon, or skin that are deemed cured by local treatment will not be included, as will prostate cancer or metachronous secondary cancers.
(7) Other cases where the investigator or other person in charge of the study deems inappropriate for safely conducting this study.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Masao |
| Middle name | |
| Last name | Murakami |
Organization
Southern Tohoku Proton Therapy Center
Division name
Department of Radiation Oncology
Zip code
963-8052
Address
7-172, Yatsuyamada, Koriyama, Fukushima, 963-8052 Japan
TEL
024-934-3888
mmuraka2013@gmail.com
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Ono |
Organization
Southern Tohoku Proton Therapy Center
Division name
Department of Radiation Oncology
Zip code
963-8052
Address
7-172, Yatsuyamada, Koriyama, Fukushima, 963-8052 Japan
TEL
024-934-3888
Homepage URL
abc1123513@gmail.com
Sponsor or person
Institute
Southern Tohoku Proton Therapy 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
Southern TOHOKU Research Institute for Neuroscience Ethics committee
Address
7-115, Yatsuyamada, Koriyama, Fukushima, 963-8563 Japan
Tel
024-934-5412
rinri@mt.strins.or.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 | 06 | Month | 16 | 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 | 05 | Month | 24 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 28 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 03 | 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
Management information
Registered date
| 2025 | Year | 06 | Month | 03 | Day |
Last modified on
| 2025 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066366
