A phase I study of stereotactic body radiotherapy with real-time tumor tracking using CyberKnife and Monte Carlo algorithm for lung tumors.

A phase I study of stereotactic body radiotherapy with real-time tumor tracking using CyberKnife and Monte Carlo algorithm for lung tumors. - A phase I study of stereotactic body radiotherapy with real-time tumor tracking using CyberKnife and Monte Carlo algorithm for lung tumors.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005061

Enrollment

Registered

2011-02-18

Start date

2011-03-01

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

lung tumor

Interventions

Stereotactic body radiotherapy using real-time tumor tracking with 45 or 50 or 55 Gy delivered in 4 fractions, once a day, twice a week.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Histologically or transbronchoscopic cytologically confirmed Primary or metastatic lung cancer diagnosed by images 2.cT1aN0M0,cT1bN0M0,cT2aN0M0(UICC7th) or lung oligometastasis within 5 cm diagnosed by images within 28 days 3.Dose constraints of the organs at risk seem to be limited within range 4.no previous radiotherapy around the lesion 5.20 years old or higher 6.ECOG-PS=0-2 7.Respiratory function (<=28 days) (1)PaO2>=60 torr (2)FEV1.0>=700 ml 8.Only tracking irradiation 9.Written informed consent

Exclusion criteria

Exclusion criteria: 1.active infection needed therapy 2.fever of 38.0 degrees centigrade or higher 3.pregnancy 4.psychiatric disorder 5.steroid administration 6.Patients who are considered to be inappropriate for this study by physicians

Design outcomes

Primary

Measure	Time frame
incidence of Grade 3 or higher radiation pneumonitis within 180 days after stereotactic body radiotherapy	—

Secondary

Measure	Time frame
Overall survival, Progression-free survival, local progression-free survival, 3-year survival, 3 year local progression free survival, Event-free survival, 3 year local control rate, pattern of progression, Grade 2 or higher radiation pneumonitis, adverse event, severe adverse event	—

Countries

Japan

Contacts

Public ContactHiromitsu Iwata

Nagoya City West Medical Center Nagoya Proton Therapy Center

cyber@syck.jp052-991-8588

Outcome results

None listed

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