Clinical trial · Interventional
A Phase II Study of Stereotactic Body Radiation Therapy in Patients With T1N0M0 Non-small Cell Lung Cancer (JCOG0403)
NCT00238875CI-TRIAL-00023986completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To evaluate the efficacy and safety of SBRT for T1N0M0 non-small cell lung cancer
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| T1N0M0 Non-small Cell Lung Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| stereotactic body radiation therapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- Procedure/Surgery: stereotactic body radiation therapy
- interventionNames
- Procedure: stereotactic body radiation therapy
Primary outcomes (1)
- measure
- 3-years overall survival
- timeFrame
- During the study conduct
Secondary outcomes (8)
- measure
- Overall survival
- timeFrame
- During the study conduct
- measure
- relapse-free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (3)
- BACKGROUNDNagata Y, Negoro Y, Aoki T, Mizowaki T, Takayama K, Kokubo M, Araki N, Mitsumori M, Sasai K, Shibamoto Y, Koga S, Yano S, Hiraoka M. Clinical outcomes of 3D conformal hypofractionated single high-dose radiotherapy for one or two lung tumors using a stereotactic body frame. Int J Radiat Oncol Biol Phys. 2002 Mar 15;52(4):1041-6. doi: 10.1016/s0360-3016(01)02731-6. PMID 11958900
- BACKGROUNDNagata Y, Takayama K, Matsuo Y, Norihisa Y, Mizowaki T, Sakamoto T, Sakamoto M, Mitsumori M, Shibuya K, Araki N, Yano S, Hiraoka M. Clinical outcomes of a phase I/II study of 48 Gy of stereotactic body radiotherapy in 4 fractions for primary lung cancer using a stereotactic body frame. Int J Radiat Oncol Biol Phys. 2005 Dec 1;63(5):1427-31. doi: 10.1016/j.ijrobp.2005.05.034. Epub 2005 Sep 19. PMID 16169670
- DERIVEDNagata Y, Hiraoka M, Shibata T, Onishi H, Kokubo M, Karasawa K, Shioyama Y, Onimaru R, Kozuka T, Kunieda E, Saito T, Nakagawa K, Hareyama M, Takai Y, Hayakawa K, Mitsuhashi N, Ishikura S. Prospective Trial of Stereotactic Body Radiation Therapy for Both Operable and Inoperable T1N0M0 Non-Small Cell Lung Cancer: Japan Clinical Oncology Group Study JCOG0403. Int J Radiat Oncol Biol Phys. 2015 Dec 1;93(5):989-96. doi: 10.1016/j.ijrobp.2015.07.2278. Epub 2015 Nov 11. PMID 26581137