Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| C000000029 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ministry of Health, Labour and Welfare, Japan | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To evaluate the efficacy and safety of SBRT for T1N0M0 non-small cell lung cancer
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Procedure/Surgery: stereotactic body radiation therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| stereotactic body radiation therapy | Procedure | Procedure/Surgery: stereotactic body radiation therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 3-years overall survival | During the study conduct |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | During the study conduct | |
| relapse-free survival | During the study conduct | |
| local-relapse free survival |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Masahiro Hiraoka, MD, PhD | Kyoto Universlty Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyushu University Hospital | Fukuoka,Higashi-ku,Maidashi,3-1-1 | Fukuoka | 812-8582 | Japan | ||
| Hiroshima University, School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11958900 | Background | 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. doi: 10.1016/s0360-3016(01)02731-6. | |
| 16169670 |
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| During the study conduct |
| 3-years local relapse free survival | During the study conduct |
| patterns of relapse | During the study conduct |
| acute complications | within 8 weeks from starting treatment day |
| late complications | after 8 weeks from starting treatment day |
| serious complication rate | During the study conduct |
| Hiroshima,Minami-ku,Kasumi,1-2-3 |
| Hiroshima |
| 734-8551 |
| Japan |
| Hokkaido University Hospital | North-14 West-5 Kita-ku,Sapporo | Hokkaido | 060-8648 | Japan |
| Sapporo Medical University | S-1,W-16,Chuo-ku,Sapporo | Hokkaido | 060-8543 | Japan |
| Institute of Biomedical Research and Innovation Hospital | Kobe,Chuo-ku,Minatojima-Minamimachi,2-2 | Hyōgo | 650-0047 | Japan |
| Kitasato University School of Medicine | Sagamihara,Kitasato,1-15-1 | Kanagawa | 228-8555 | Japan |
| Kyoto Universlty Hospital | Kyoto,Sakyoku,Shogoin,Kawahara-cho,54 | Kyoto | 606-8507 | Japan |
| Tohoku University Hospital | Sendai,Aoba-ku,Seiryo-machi,1-1 | Miyagi | 980-8574 | Japan |
| Tenri Hospital | Tenri,Mishima-cho,200 | Nara | 632-8552 | Japan |
| The University of Tokyo Hospital | Bunkyo-ku,Hongo,7-3-1 | Tokyo | 113-8655 | Japan |
| Tokyo Metropolitan Komagome Hospital | Bunkyo-ku,Honkomagome,3-18-22 | Tokyo | 113-8677 | Japan |
| Nihon University Itabashi Hospital | Itabashi-ku,Oyaguchikamimachi,30-1 | Tokyo | 173-8610 | Japan |
| Cancer Institute Hospital | Koto-ku,Ariake,3-10-6 | Tokyo | 135-8550 | Japan |
| Tokyo Women's Medical University | Shinjuku-ku,Kawada-cho,8-1 | Tokyo | 162-8666 | Japan |
| Keio University Hospital | Shinjuku-ku,Shinanomachi,35 | Tokyo | 160-8582 | Japan |
| University of Yamanashi Faculty of Medicine | Nakakoma,Tamaho,Shimokato,1110 | Yamanashi | 409-3898 | Japan |
| 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. doi: 10.1016/j.ijrobp.2005.05.034. Epub 2005 Sep 19. |
| 26581137 | Derived | Nagata 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. |
| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
Not provided
Not provided