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
cancer
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:
Interventional
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:
No
Principal Investigator
Masahiro Hiraoka, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Kyoto Universlty Hospital
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
JCOG0403
NCT ID:
NCT00238875
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
