T1N0M0 Non-small Cell Lung Cancer Clinical Trial
Official title:
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
| Status | Completed |
| Enrollment | 167 |
| Est. completion date | November 2011 |
| Est. primary completion date | November 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 20 Years and older |
| Eligibility |
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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Japan | The University of Tokyo Hospital | Bunkyo-ku,Hongo,7-3-1 | Tokyo |
| Japan | Tokyo Metropolitan Komagome Hospital | Bunkyo-ku,Honkomagome,3-18-22 | Tokyo |
| Japan | Kyushu University Hospital | Fukuoka,Higashi-ku,Maidashi,3-1-1 | Fukuoka |
| Japan | Hiroshima University, School of Medicine | Hiroshima,Minami-ku,Kasumi,1-2-3 | Hiroshima |
| Japan | Nihon University Itabashi Hospital | Itabashi-ku,Oyaguchikamimachi,30-1 | Tokyo |
| Japan | Institute of Biomedical Research and Innovation Hospital | Kobe,Chuo-ku,Minatojima-Minamimachi,2-2 | Hyogo |
| Japan | Cancer Institute Hospital | Koto-ku,Ariake,3-10-6 | Tokyo |
| Japan | Kyoto Universlty Hospital | Kyoto,Sakyoku,Shogoin,Kawahara-cho,54 | Kyoto |
| Japan | University of Yamanashi Faculty of Medicine | Nakakoma,Tamaho,Shimokato,1110 | Yamanashi |
| Japan | Hokkaido University Hospital | North-14 West-5 Kita-ku,Sapporo | Hokkaido |
| Japan | Sapporo Medical University | S-1,W-16,Chuo-ku,Sapporo | Hokkaido |
| Japan | Kitasato University School of Medicine | Sagamihara,Kitasato,1-15-1 | Kanagawa |
| Japan | Tohoku University Hospital | Sendai,Aoba-ku,Seiryo-machi,1-1 | Miyagi |
| Japan | Tokyo Women's Medical University | Shinjuku-ku,Kawada-cho,8-1 | Tokyo |
| Japan | Keio University Hospital | Shinjuku-ku,Shinanomachi,35 | Tokyo |
| Japan | Tenri Hospital | Tenri,Mishima-cho,200 | Nara |
| Lead Sponsor | Collaborator |
|---|---|
| Haruhiko Fukuda | Ministry of Health, Labour and Welfare, Japan |
Japan,
Nagata 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. — View Citation
Nagata 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. Epub 2005 Sep 19. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 3-years overall survival | During the study conduct | No | |
| Secondary | Overall survival | During the study conduct | No | |
| Secondary | relapse-free survival | During the study conduct | No | |
| Secondary | local-relapse free survival | During the study conduct | No | |
| Secondary | 3-years local relapse free survival | During the study conduct | No | |
| Secondary | patterns of relapse | During the study conduct | No | |
| Secondary | acute complications | within 8 weeks from starting treatment day | Yes | |
| Secondary | late complications | after 8 weeks from starting treatment day | Yes | |
| Secondary | serious complication rate | During the study conduct | Yes |