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

Haruhiko Fukuda

Status and phase: Completed; Phase 2

Conditions: T1N0M0 Non-small Cell Lung Cancer

Treatments: Procedure: stereotactic body radiation therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00238875

JCOG0403

C000000029

Details and patient eligibility

About

To evaluate the efficacy and safety of SBRT for T1N0M0 non-small cell lung cancer

Full description

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.

Enrollment: 167 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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167 participants in 1 patient group

1

Experimental group

Description:

Procedure/Surgery: stereotactic body radiation therapy

Treatment:

Procedure: stereotactic body radiation therapy