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A phase I study of stereotactic body radiation therapy in patients with T2N0M0 non-small cell lung cancer (JCOG0702)

A phase I study of stereotactic body radiation therapy in patients with T2N0M0 non-small cell lung cancer (JCOG0702) - A phase I study of stereotactic body radiation therapy in patients with T2N0M0 non-small cell lung cancer (JCOG0702)

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000001459
Enrollment
60
Registered
2008-10-29
Start date
2008-10-01
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

T2N0M0 non-small cell lung cancer

Interventions

Stereotactic body radiotherapy

Sponsors

Japan Clinical Oncology Group(JCOG)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Histologically or transbronchoscopic cytologically confirmed non-small cell lung cancer 2.Stage IB with images within 35 days 3.No other intrathoracic lesions 4.Dose constraints of the organs at risk seem to be limited within range 5.Operable (Standard or Limited surgery) >=70 years old who refusee operation or Inoperable >=20 6.No previous thoracic radiation 7.No previous chemotherapy 8.ECOG PS=0-2 9.No dyspnea on effort 10.Respiratory function (<=35 days) PaO2>=60 torr FEV1.0>=700 ml 11.Written informed consent

Exclusion criteria

Exclusion criteria: 1. apparent interstitial pneumonitis and fibrosis 2. active inflamation without oral drugs 3. double cancer 4. pregnancy 5. psychiatric disorder 6. steroid administration 7. oxygen administration 8. fever of 38.0 degrees centigrade or higher 9. narcotics administration for coughing

Design outcomes

Primary

MeasureTime frame
incidence of Grade 2 or more radiation pneumonits within 180 days after stereotactic radiotherapy

Secondary

MeasureTime frame
overall survival, 3-year survival, progression free survival, local progression free survival, 3-year local progression free survival, event free survival, pattern of failure, incidence of Grade 3 or more radiation pneumonitis, adverse events, severe adverse events

Countries

Japan

Contacts

Public ContactRikiya Onimaru

JCOG0702 Coordinating Office Hokkaido University Hospital Radiology Division

JCOG_sir@ml.jcog.jp011-706-5977

Outcome results

None listed

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