A Phase II Study of Stereotactic Body Radiation Therapy in Patients With T1N0M0 Non-small Cell Lung Cancer (JCOG0403)
NCT ID: NCT00238875
Last Updated: 2016-09-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
167 participants
INTERVENTIONAL
2004-07-31
2011-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
Procedure/Surgery: stereotactic body radiation therapy
stereotactic body radiation therapy
Procedure/Surgery: stereotactic body radiation therapy
Interventions
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stereotactic body radiation therapy
Procedure/Surgery: stereotactic body radiation therapy
Eligibility Criteria
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Inclusion Criteria
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
2. No active tuberculosis without oral drugs
3. No double cancer
4. No pregnancy
5. No psychiatric disorder
6. No steroid administration
20 Years
ALL
No
Sponsors
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Ministry of Health, Labour and Welfare, Japan
OTHER_GOV
Haruhiko Fukuda
OTHER
Responsible Party
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Haruhiko Fukuda
JCOG Data Center
Principal Investigators
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Masahiro Hiraoka, MD, PhD
Role: STUDY_CHAIR
Kyoto Universlty Hospital
Locations
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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
Hokkaido University Hospital
North-14 West-5 Kita-ku,Sapporo, Hokkaido, Japan
Sapporo Medical University
S-1,W-16,Chuo-ku,Sapporo, Hokkaido, Japan
Institute of Biomedical Research and Innovation Hospital
Kobe,Chuo-ku,Minatojima-Minamimachi,2-2, Hyōgo, Japan
Kitasato University School of Medicine
Sagamihara,Kitasato,1-15-1, Kanagawa, Japan
Kyoto Universlty Hospital
Kyoto,Sakyoku,Shogoin,Kawahara-cho,54, Kyoto, Japan
Tohoku University Hospital
Sendai,Aoba-ku,Seiryo-machi,1-1, Miyagi, Japan
Tenri Hospital
Tenri,Mishima-cho,200, Nara, 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
Nihon University Itabashi Hospital
Itabashi-ku,Oyaguchikamimachi,30-1, Tokyo, Japan
Cancer Institute Hospital
Koto-ku,Ariake,3-10-6, Tokyo, Japan
Tokyo Women's Medical University
Shinjuku-ku,Kawada-cho,8-1, Tokyo, Japan
Keio University Hospital
Shinjuku-ku,Shinanomachi,35, Tokyo, Japan
University of Yamanashi Faculty of Medicine
Nakakoma,Tamaho,Shimokato,1110, Yamanashi, Japan
Countries
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References
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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.
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.
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.
Related Links
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Related Info
Other Identifiers
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C000000029
Identifier Type: -
Identifier Source: secondary_id
JCOG0403
Identifier Type: -
Identifier Source: org_study_id
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