T1N0M0 Non-small Cell Lung CancerPhase 2NCT00238875
A Phase II Study of Stereotactic Body Radiation Therapy in Patients With T1N0M0 Non-small Cell Lung Cancer (JCOG0403)
A Phase 2 study testing stereotactic body radiation therapy in people with T1N0M0 Non-small Cell Lung Cancer, run by Haruhiko Fukuda at 16 sites in Japan.
Trial summary
To evaluate the efficacy and safety of SBRT for T1N0M0 non-small cell lung cancer Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- T1N0M0 Non-small Cell Lung Cancer
- What is being tested?
- stereotactic body radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 16 sitesJapan
- Study dates
- Jul 2004to Nov 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- No apparent radiation pneumonitis and fibrosis
- No active tuberculosis without oral drugs
- No double cancer
- No pregnancy
- No psychiatric disorder
- No steroid administration
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
Japan16 sites
The University of Tokyo Hospital
Bunkyo-ku,Hongo,7-3-1, Tokyo, 113-8655
Tokyo Metropolitan Komagome Hospital
Bunkyo-ku,Honkomagome,3-18-22, Tokyo, 113-8677
Kyushu University Hospital
Fukuoka,Higashi-ku,Maidashi,3-1-1, Fukuoka, 812-8582
Hiroshima University, School of Medicine
Hiroshima,Minami-ku,Kasumi,1-2-3, Hiroshima, 734-8551
Nihon University Itabashi Hospital
Itabashi-ku,Oyaguchikamimachi,30-1, Tokyo, 173-8610
Institute of Biomedical Research and Innovation Hospital
Kobe,Chuo-ku,Minatojima-Minamimachi,2-2, Hyōgo, 650-0047
Cancer Institute Hospital
Koto-ku,Ariake,3-10-6, Tokyo, 135-8550
Kyoto Universlty Hospital
Kyoto,Sakyoku,Shogoin,Kawahara-cho,54, Kyoto, 606-8507
University of Yamanashi Faculty of Medicine
Nakakoma,Tamaho,Shimokato,1110, Yamanashi, 409-3898
Hokkaido University Hospital
North-14 West-5 Kita-ku,Sapporo, Hokkaido, 060-8648
Sapporo Medical University
S-1,W-16,Chuo-ku,Sapporo, Hokkaido, 060-8543
Kitasato University School of Medicine
Sagamihara,Kitasato,1-15-1, Kanagawa, 228-8555
Tohoku University Hospital
Sendai,Aoba-ku,Seiryo-machi,1-1, Miyagi, 980-8574
Tokyo Women's Medical University
Shinjuku-ku,Kawada-cho,8-1, Tokyo, 162-8666
Keio University Hospital
Shinjuku-ku,Shinanomachi,35, Tokyo, 160-8582
Tenri Hospital
Tenri,Mishima-cho,200, Nara, 632-8552
About this study
To evaluate the efficacy and safety of SBRT for T1N0M0 non-small cell lung cancer
Read the 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.
- Conditions
- T1N0M0 Non-small Cell Lung Cancer
- Being tested
- stereotactic body radiation therapy
- Keywords
- stereotactic body radiation therapy, T1N0M0 non-small cell lung cancer, radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stereotactic body radiation therapyProcedure or surgery
Procedure/Surgery: stereotactic body radiation therapy
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Procedure/Surgery: stereotactic body radiation therapy Receives: Procedure: stereotactic body radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-years overall survival
Measured: During the study conduct
Secondary outcomes (8)
Overall survival
Measured: During the study conduct
relapse-free survival
Measured: During the study conduct
local-relapse free survival
Measured: During the study conduct
3-years local relapse free survival
Measured: During the study conduct
patterns of relapse
Measured: During the study conduct
acute complications
Measured: within 8 weeks from starting treatment day
late complications
Measured: after 8 weeks from starting treatment day
serious complication rate
Measured: During the study conduct
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2005 (estimated)
- Study startJul 2004
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for T1N0M0 Non-small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haruhiko Fukuda
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Labour and Welfare, Japan
- Responsible party
- Sponsor-investigator, Haruhiko Fukuda, Japan Clinical Oncology Group
- Investigators
- Masahiro Hiraoka, MD, PhD, Study chair, Kyoto Universlty Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00238875
- Sponsor's protocol ID
- JCOG0403
- Other IDs
- C000000029
- Status last verified
- Sep 2016
- First submitted
- 13 Oct 2005
- Last updated
- 22 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 11958900Nagata 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.
PubMed 16169670Nagata 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.
PubMed 26581137
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Stereotactic Body Radiation Therapy in Patients With T1N0M0 Non-small Cell Lung Cancer (JCOG0403)
- ClinicalTrials.gov ID
- NCT00238875
- Acronym / sponsor ID
- JCOG0403
- Conditions
- T1N0M0 Non-small Cell Lung Cancer
- Keywords
- stereotactic body radiation therapy, T1N0M0 non-small cell lung cancer, radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Haruhiko FukudaUniversity, hospital or other
- Collaborators
- Ministry of Health, Labour and Welfare, Japan
- Study start
- Jul 2004
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 14 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: stereotactic body radiation therapyProcedure/Surgery: stereotactic body radiation therapy |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (6 listed)
- No apparent radiation pneumonitis and fibrosis
- No active tuberculosis without oral drugs
- No double cancer
- No pregnancy
- No psychiatric disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stereotactic body radiation therapyProcedure/Surgery: stereotactic body radiation therapy | Procedure or surgery | 1 |
Primary outcome
3-years overall survival
Time frame: During the study conduct
8 secondary outcomes
Overall survival
Time frame: During the study conduct
relapse-free survival
Time frame: During the study conduct
local-relapse free survival
Time frame: During the study conduct
3-years local relapse free survival
Time frame: During the study conduct
patterns of relapse
Time frame: During the study conduct
acute complications
Time frame: within 8 weeks from starting treatment day
late complications
Time frame: after 8 weeks from starting treatment day
serious complication rate
Time frame: During the study conduct
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2016.
- Background: PubMed 11958900Nagata 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.
- Background: PubMed 16169670Nagata 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.
- Derived from this study: PubMed 26581137Nagata 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 InfoLink provided by the sponsor.
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Recruiting
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Masahiro Hiraoka, MD, PhD study chair
Kyoto Universlty Hospital
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing stereotactic body radiation therapy in people with T1N0M0 Non-small Cell Lung Cancer, run by Haruhiko Fukuda at 16 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-years overall survival (time frame: During the study conduct). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00238875, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2016.