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A Phase II Study of Stereotactic Body Radiation Therapy in Patients With T1N0M0 Non-Small Cell Lung Cancer (JCOG0403)

Phase 2
20 Years
Open (Enrolling)
T1N0M0 Non-Small Cell Lung Cancer

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Trial Information

A Phase II Study of Stereotactic Body Radiation Therapy in Patients With T1N0M0 Non-Small Cell Lung Cancer (JCOG0403)

To evaluate the efficacy and safety of SBRT for T1N0M0 non-small cell lung cancer,the
following questions should be answered. Can SRT be an alternative standard treatment
modality for inoperable patients? Can SRT can be a comparable standard treatment modality
with lobectomy for operable patients? 12 Gy is the daily dose at the isocenter,and 48 Gy in
total by 4 fractions will be irradiated by stereotactic irradiation over 4 to 8 days.

Inclusion Criteria:

1. Histologically or transbronchoscopic cytologically confirmed non-small cell lung

2. Stage IA with images within 28 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) or Inoperable

6. Age>=20

7. No previous thoracic radiation

8. No previous chemotherapy

9. ECOG PS=0-2

10. Respiratory function (<=14 days) PaO2>=60 torr FEV1.0>=700 ml

11. Written informed consent

Exclusion Criteria:

1. No apparent radiation pneumonitis and fibrosis

2. No active tuberculosis without oral drugs

3. No double cancer

4. No pregnancy

5. No psychiatric disorder

6. No steroid administration

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

3-years overall survival

Outcome Time Frame:

During the study conduct

Safety Issue:


Principal Investigator

Masahiro Hiraoka, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Kyoto Universlty Hospital


Japan: Ministry of Health, Labor and Welfare

Study ID:




Start Date:

July 2004

Completion Date:

November 2011

Related Keywords:

  • T1N0M0 Non-Small Cell Lung Cancer
  • stereotactic body radiation therapy
  • T1N0M0 non-small cell lung cancer
  • radiotherapy
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms