A phase II clinical trial of carbon-ion radiotherapy for patients with peripherally located stage I non-small-cell lung cancer

A phase II clinical trial of carbon-ion radiotherapy for patients with peripherally located stage I non-small-cell lung cancer - phase II trial of carbon-ion radiotherapy for preipherally located stage I non-small-cell lung cancer

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000023075

Enrollment

Registered

2016-07-08

Start date

2014-04-01

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

Peripheraly located stage I non-small-cell lung cancer

Interventions

Carbon-ion radiotherapy T1:54.0GyRBE/4fractions T2:64.0GyRBE/4fractions

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Pathologically confirmed NSCLC 2)Clinically T1-T2aN0M0 diagnosed by imaging examinations including FDG-PET 3)No history of thoracic irradiation 4)Medically inoperable or refuse surgery 5)Exist of lesion for evaluation 6)No history of chemotherapy within 2 weeks 7)20 year-old or > 20 year-old 8)Estimated survival longer than 6 months 9)Informed consent by document

Exclusion criteria

Exclusion criteria: 1)Interstitial pneumonitis on CT images 2)< SpO2 94% 3)Severe infections in treatment area 4)Coexisting malignancies within 2 years excepting Carcinoma in Situ, stgae I laryngeal cancer, localized prostate cancer 5)Pregnancy 6)Unfit due to mental disorders 7)Continuouslly oral or intravenous administration of steroid 8)Other reasons judged by physician

Design outcomes

Primary

Measure	Time frame
3-year local control rate	—

Secondary

Measure	Time frame
3- and 5-year overall survival rate 3- and 5-year cause-specific survival rate 3- and 5-year progression-free survival rate Toxicities Pulmonary function (VC, FEV1.0) at 3 years	—

Countries

Japan

Contacts

Public ContactYoshiyuki Shioyama

Ion Beam Therapy Center, SAGA-HIMAT Foundation Department of Radiation Oncology

shioyama-yoshiyuki@saga-himat.jp0942-81-1897

Outcome results

None listed

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