Clinical trial of four-fraction proton beam therapy for localized and peripheral lung cancer

Clinical trial of four-fraction proton beam irradiation for peripheral stage I-IIA lung cancer - Four-fraction proton beam irradiation for peripheral lung cancer

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000058065

Enrollment

Registered

2025-06-16

Start date

2025-06-03

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung cancer

Interventions

Four-fraction proton beam therapy

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
3-year survival rate	—

Countries

Japan

Contacts

Public ContactTakashi Ono

Southern Tohoku Proton Therapy Center Department of Radiation Oncology

abc1123513@gmail.com024-934-3888

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026