A Phase II Study of Stereotactic Body Radiation Therapy in Patients With T1N0M0 Non-small Cell Lung Cancer (JCOG0403)
2 other identifiers
interventional
167
1 country
16
Brief Summary
To evaluate the efficacy and safety of SBRT for T1N0M0 non-small cell lung cancer
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2004
Longer than P75 for phase_2
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2004
CompletedFirst Submitted
Initial submission to the registry
October 13, 2005
CompletedFirst Posted
Study publicly available on registry
October 14, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedSeptember 22, 2016
September 1, 2016
7.3 years
October 13, 2005
September 21, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
3-years overall survival
During the study conduct
Secondary Outcomes (8)
Overall survival
During the study conduct
relapse-free survival
During the study conduct
local-relapse free survival
During the study conduct
3-years local relapse free survival
During the study conduct
patterns of relapse
During the study conduct
- +3 more secondary outcomes
Study Arms (1)
1
EXPERIMENTALProcedure/Surgery: stereotactic body radiation therapy
Interventions
Eligibility Criteria
You may qualify if:
- Histologically or transbronchoscopic cytologically confirmed non-small cell lung cancer
- Stage IA with images within 28 days
- No other intrathoracic lesions
- Dose constraints of the organs at risk seem to be limited within range
- Operable (Standard or Limited surgery) or Inoperable
- Age\>=20
- No previous thoracic radiation
- No previous chemotherapy
- ECOG PS=0-2
- Respiratory function (\<=14 days) PaO2\>=60 torr FEV1.0\>=700 ml
- Written informed consent
You may not qualify if:
- No apparent radiation pneumonitis and fibrosis
- No active tuberculosis without oral drugs
- No double cancer
- No pregnancy
- No psychiatric disorder
- No steroid administration
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Haruhiko Fukudalead
- Ministry of Health, Labour and Welfare, Japancollaborator
Study Sites (16)
Kyushu University Hospital
Fukuoka,Higashi-ku,Maidashi,3-1-1, Fukuoka, 812-8582, Japan
Hiroshima University, School of Medicine
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
Related Publications (3)
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.
PMID: 11958900BACKGROUNDNagata 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: 16169670BACKGROUNDNagata 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: 26581137DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Masahiro Hiraoka, MD, PhD
Kyoto Universlty Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- JCOG Data Center
Study Record Dates
First Submitted
October 13, 2005
First Posted
October 14, 2005
Study Start
July 1, 2004
Primary Completion
November 1, 2011
Study Completion
November 1, 2011
Last Updated
September 22, 2016
Record last verified: 2016-09