A phase 2 study of proton therapy for inoperable stage I non-small cell lung cancer

A phase 2 study of proton therapy for inoperable stage I non-small cell lung cancer - Proton therapy for inoperable stage I non-small cell lung cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000045504

Enrollment

Registered

2021-10-01

Start date

2013-08-13

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

Stage I non-small cell lung cancer

Interventions

Proton therapy (66 GyRBE in 10 fractions over 2 weeks or 72.6 GyRBE in 22 fractions over 4.4 weeks)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically or transbronchoscopic cytologically confirmed non-small cell lung cancer 2) Clinical stage IA or IB (7th edition of TNM staging of Union for International Cancer Control) within 28 days 3) ECOG peformance status of 0-2 4) Age>=20 5) Capable of maintaining their position during irradiation 6) Dose constraints of the organs at risk seem to be limited within range 7) No previous radiotherapy around the lesion 8) No previous chemotherapy 9) Inoperable judged by the surgeon 10) Respiratory function (<=28 days) PaO2 in room air >=60 Torr and forced expiratory volume 1.0 >=700 mL 11) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Pregnancy 2) Synchronous or metachronous cancer 3) Active infectious disease 4) Other severe comorbidities 5) Severe psychological disorder 6) Apparent interstitial pneumonitis or pulmonary fibrosis detectable by chest X-ray radiography 7) Judged as inappropriate to participation by investigators

Design outcomes

Primary

Measure	Time frame
The rate of grade 3 and higher radiation pneumonitis within 180 days after the start of irradiation	—

Secondary

Measure	Time frame
Local control rate, overall survival period, progression-free survival period, event-free survival period, local progression-free survival period, patterns of failure, adverse event, QOL	—

Countries

Japan

Contacts

Public ContactKoichiro Nakajima

Nagoya city University West Medical Center, Nagoya Proton Therapy Center Radiation oncology

k.nakajima.ncu@gmail.com052-991-8577

Outcome results

None listed

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