Back to resultsA Phase II Study of Stereotactic Body Radiation Therapy in Patients With T1N0M0 Non-small Cell Lung Cancer (JCOG0403)
Primary Purpose
T1N0M0 Non-small Cell Lung Cancer
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
stereotactic body radiation therapy
Sponsored by
About this trial
This is an interventional treatment trial for T1N0M0 Non-small Cell Lung Cancer focused on measuring stereotactic body radiation therapy, T1N0M0 non-small cell lung cancer, radiotherapy
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: No apparent radiation pneumonitis and fibrosis No active tuberculosis without oral drugs No double cancer No pregnancy No psychiatric disorder No steroid administration
Sites / Locations
- Kyushu University Hospital
- Hiroshima University, School of Medicine
- Hokkaido University Hospital
- Sapporo Medical University
- Institute of Biomedical Research and Innovation Hospital
- Kitasato University School of Medicine
- Kyoto Universlty Hospital
- Tohoku University Hospital
- Tenri Hospital
- The University of Tokyo Hospital
- Tokyo Metropolitan Komagome Hospital
- Nihon University Itabashi Hospital
- Cancer Institute Hospital
- Tokyo Women's Medical University
- Keio University Hospital
- University of Yamanashi Faculty of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Procedure/Surgery: stereotactic body radiation therapy
Outcomes
Primary Outcome Measures
3-years overall survival
Secondary Outcome Measures
Overall survival
relapse-free survival
local-relapse free survival
3-years local relapse free survival
patterns of relapse
acute complications
late complications
serious complication rate
Full Information
NCT ID
NCT00238875
First Posted
October 13, 2005
Last Updated
September 21, 2016
Sponsor
Haruhiko Fukuda
Collaborators
Ministry of Health, Labour and Welfare, Japan
1. Study Identification
Unique Protocol Identification Number
NCT00238875
Brief Title
A Phase II Study of Stereotactic Body Radiation Therapy in Patients With T1N0M0 Non-small Cell Lung Cancer (JCOG0403)
Official Title
A Phase II Study of Stereotactic Body Radiation Therapy in Patients With T1N0M0 Non-small Cell Lung Cancer (JCOG0403)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Haruhiko Fukuda
Collaborators
Ministry of Health, Labour and Welfare, Japan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To evaluate the efficacy and safety of SBRT for T1N0M0 non-small cell lung cancer
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
T1N0M0 Non-small Cell Lung Cancer
Keywords
stereotactic body radiation therapy, T1N0M0 non-small cell lung cancer, radiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
167 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Procedure/Surgery: stereotactic body radiation therapy
Intervention Type
Procedure
Intervention Name(s)
stereotactic body radiation therapy
Intervention Description
Procedure/Surgery: stereotactic body radiation therapy
Primary Outcome Measure Information:
Title
3-years overall survival
Time Frame
During the study conduct
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
During the study conduct
Title
relapse-free survival
Time Frame
During the study conduct
Title
local-relapse free survival
Time Frame
During the study conduct
Title
3-years local relapse free survival
Time Frame
During the study conduct
Title
patterns of relapse
Time Frame
During the study conduct
Title
acute complications
Time Frame
within 8 weeks from starting treatment day
Title
late complications
Time Frame
after 8 weeks from starting treatment day
Title
serious complication rate
Time Frame
During the study conduct
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
No apparent radiation pneumonitis and fibrosis
No active tuberculosis without oral drugs
No double cancer
No pregnancy
No psychiatric disorder
No steroid administration
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Masahiro Hiraoka, MD, PhD
Organizational Affiliation
Kyoto Universlty Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Kyushu University Hospital
City
Fukuoka,Higashi-ku,Maidashi,3-1-1
State/Province
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Hiroshima University, School of Medicine
City
Hiroshima,Minami-ku,Kasumi,1-2-3
State/Province
Hiroshima
ZIP/Postal Code
734-8551
Country
Japan
Facility Name
Hokkaido University Hospital
City
North-14 West-5 Kita-ku,Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
Sapporo Medical University
City
S-1,W-16,Chuo-ku,Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8543
Country
Japan
Facility Name
Institute of Biomedical Research and Innovation Hospital
City
Kobe,Chuo-ku,Minatojima-Minamimachi,2-2
State/Province
Hyogo
ZIP/Postal Code
650-0047
Country
Japan
Facility Name
Kitasato University School of Medicine
City
Sagamihara,Kitasato,1-15-1
State/Province
Kanagawa
ZIP/Postal Code
228-8555
Country
Japan
Facility Name
Kyoto Universlty Hospital
City
Kyoto,Sakyoku,Shogoin,Kawahara-cho,54
State/Province
Kyoto
ZIP/Postal Code
606-8507
Country
Japan
Facility Name
Tohoku University Hospital
City
Sendai,Aoba-ku,Seiryo-machi,1-1
State/Province
Miyagi
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
Tenri Hospital
City
Tenri,Mishima-cho,200
State/Province
Nara
ZIP/Postal Code
632-8552
Country
Japan
Facility Name
The University of Tokyo Hospital
City
Bunkyo-ku,Hongo,7-3-1
State/Province
Tokyo
ZIP/Postal Code
113-8655
Country
Japan
Facility Name
Tokyo Metropolitan Komagome Hospital
City
Bunkyo-ku,Honkomagome,3-18-22
State/Province
Tokyo
ZIP/Postal Code
113-8677
Country
Japan
Facility Name
Nihon University Itabashi Hospital
City
Itabashi-ku,Oyaguchikamimachi,30-1
State/Province
Tokyo
ZIP/Postal Code
173-8610
Country
Japan
Facility Name
Cancer Institute Hospital
City
Koto-ku,Ariake,3-10-6
State/Province
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Tokyo Women's Medical University
City
Shinjuku-ku,Kawada-cho,8-1
State/Province
Tokyo
ZIP/Postal Code
162-8666
Country
Japan
Facility Name
Keio University Hospital
City
Shinjuku-ku,Shinanomachi,35
State/Province
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Facility Name
University of Yamanashi Faculty of Medicine
City
Nakakoma,Tamaho,Shimokato,1110
State/Province
Yamanashi
ZIP/Postal Code
409-3898
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
11958900
Citation
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.
Results Reference
background
PubMed Identifier
16169670
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. doi: 10.1016/j.ijrobp.2005.05.034. Epub 2005 Sep 19.
Results Reference
background
PubMed Identifier
26581137
Citation
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.
Results Reference
derived
Links:
URL
http://www.jcog.jp/
Description
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A Phase II Study of Stereotactic Body Radiation Therapy in Patients With T1N0M0 Non-small Cell Lung Cancer (JCOG0403)
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