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A phase II clinical trial of carbon-ion radiotherapyfor patients with centrally located stage I non-small-cell lung cancer

A phase II clinical trial of carbon-ion radiotherapyfor patients with centrally located stage I non-small-cell lung cancer - A phase II clinical trial of carbon-ion radiotherapyfor patients with centrally located stage I non-small-cell lung cancer

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000023076
Enrollment
20
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

Centrally located stage I non-small-cell lung cancer

Interventions

Carbon-ion radiotherapy 68.4GyRBE/12fractions

Sponsors

Ion Beam Therapy Center, SAGA-HIMAT Foundation
Lead Sponsor

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)Centrally located 7)No history of chemotherapy within 2 weeks 8)20 year-old or > 20 year-old 9) PS(ECOG)0-2 10)Estimated survival longer than 6 months 11)Writtened informed consent

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

MeasureTime frame
3-year local control rate

Secondary

MeasureTime 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