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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN C000000029
Receipt No. R000000063
Scientific Title A phase II study of stereotactic body radiation therapy in patients with T1N0M0 non-small cell lung cancer (JCOG0403)
Date of disclosure of the study information 2005/07/28
Last modified on 2015/11/20

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Basic information
Public title A phase II study of stereotactic body radiation therapy in patients with T1N0M0 non-small cell lung cancer (JCOG0403)
Acronym A phase II study of stereotactic body radiation therapy in patients with T1N0M0 non-small cell lung cancer (JCOG0403)
Scientific Title A phase II study of stereotactic body radiation therapy in patients with T1N0M0 non-small cell lung cancer (JCOG0403)
Scientific Title:Acronym A phase II study of stereotactic body radiation therapy in patients with T1N0M0 non-small cell lung cancer (JCOG0403)
Region
Japan

Condition
Condition T1N0M0 non-small cell lung cancer
Classification by specialty
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of SBRT for T1N0M0 non-small cell lung cancer
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes 3-years overall survival
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 stereotactic body radiation therapy
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.Histologically or transbronchoscopic cytologically confirmed non-small cell lung cancer
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
Key exclusion criteria 1. No apparent interstitial pneumonitis and fibrosis
2. No active inflamation without oral drugs
3. No double cancer
4. No pregnancy
5. No psychiatric disorder
6. No steroid administration
Target sample size 169

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahiro Hiraoka, M.D., P.h.D.
Organization Kyoto Universlty Hospital
Division name Dept. of Radiation Oncology and Image-applied Therapy
Zip code
Address 54 Kawahara-cho,Shogoin, Sakyo, Kyoto, 606-8507 Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yasushi Nagata, M.D.
Organization JCOG0403 Coordinating Office
Division name Division of Radiation Oncology, Hiroshima University Hospital
Zip code
Address 1-2-3 Kasumi, Minami-ku, Hiroshima-shi, Hiroshima, Japan 734-8551
TEL
Homepage URL http://www.jcog.jp/
Email JCOG_sir@ml.jcog.jp

Sponsor
Institute Japan Clinical Oncology Group(JCOG)
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 NCT00238875
Org. issuing International ID_1 ClinicalTrials.gov by NLM
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 北海道大学病院(北海道)
札幌医科大学(北海道)
東北大学病院(宮城県)
がん・感染症センター都立駒込病院(東京都)
東京女子医科大学(東京都)
慶應義塾大学病院(東京都)
がん研究会有明病院(東京都)
東京大学医学部(東京都)
北里大学医学部(神奈川県)
山梨大学医学部(山梨県)
京都大学医学部附属病院(京都府)
先端医療センター(兵庫県)
広島大学病院(広島県)
九州大学病院(福岡県)

Other administrative information
Date of disclosure of the study information
2005 Year 07 Month 28 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.redjournal.org/article/S0360-3016(15)03069-2/abstract
Number of participants that the trial has enrolled
Results
See the datails via "URL releasing results" above.
Also the details can be seen in the JCOG website: 
http://www.jcog.jp/en/trials/index.html
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2004 Year 06 Month 24 Day
Date of IRB
Anticipated trial start date
2004 Year 07 Month 01 Day
Last follow-up date
2017 Year 02 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2005 Year 07 Month 27 Day
Last modified on
2015 Year 11 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000063

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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