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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000001459
Receipt No. R000001770
Scientific Title A phase I study of stereotactic body radiation therapy in patients with T2N0M0 non-small cell lung cancer (JCOG0702)
Date of disclosure of the study information 2008/10/29
Last modified on 2015/09/11

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Basic information
Public title A phase I study of stereotactic body radiation therapy in patients with T2N0M0 non-small cell lung cancer (JCOG0702)
Acronym A phase I study of stereotactic body radiation therapy in patients with T2N0M0 non-small cell lung cancer (JCOG0702)
Scientific Title A phase I study of stereotactic body radiation therapy in patients with T2N0M0 non-small cell lung cancer (JCOG0702)
Scientific Title:Acronym A phase I study of stereotactic body radiation therapy in patients with T2N0M0 non-small cell lung cancer (JCOG0702)
Region
Japan

Condition
Condition T2N0M0 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 T2N0M0 non-small cell lung cancer (phase I study)
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes incidence of Grade 2 or more radiation pneumonits within 180 days after stereotactic radiotherapy
Key secondary outcomes overall survival, 3-year survival, progression free survival, local progression free survival, 3-year local progression free survival, event free survival, pattern of failure, incidence of Grade 3 or more radiation pneumonitis, adverse events, severe adverse events

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
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 radiotherapy
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 IB with images within 35 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) >=70 years old who refusee operation or Inoperable >=20
6.No previous thoracic radiation
7.No previous chemotherapy
8.ECOG PS=0-2
9.No dyspnea on effort
10.Respiratory function (<=35 days)
PaO2>=60 torr
FEV1.0>=700 ml
11.Written informed consent
Key exclusion criteria 1. apparent interstitial pneumonitis and fibrosis
2. active inflamation without oral drugs
3. double cancer
4. pregnancy
5. psychiatric disorder
6. steroid administration
7. oxygen administration
8. fever of 38.0 degrees centigrade or higher
9. narcotics administration for coughing
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroki Shirato
Organization Hokkaido University Hospital
Division name Radiology Division
Zip code
Address North14 West5, Kitaku, Sapporo, Hokkaido, 060-8648 Japan
TEL 011-706-5977
Email

Public contact
Name of contact person
1st name
Middle name
Last name Rikiya Onimaru
Organization JCOG0702 Coordinating Office
Division name Hokkaido University Hospital Radiology Division
Zip code
Address North14 West5, Kitaku, Sapporo, Hokkaido, 060-8648 Japan
TEL 011-706-5977
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 NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 北海道大学病院(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)
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)
九州大学病院(福岡県)

Other administrative information
Date of disclosure of the study information
2008 Year 10 Month 29 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/26233591
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
2008 Year 07 Month 07 Day
Date of IRB
Anticipated trial start date
2008 Year 10 Month 01 Day
Last follow-up date
2016 Year 10 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
2008 Year 10 Month 29 Day
Last modified on
2015 Year 09 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001770

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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