UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001459 |
|---|---|
| Receipt number | 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 | 2022/08/30 17:26:14 |
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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
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/
JCOG_sir@ml.jcog.jp
Sponsor or person
Institute
Japan Clinical Oncology Group(JCOG)
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2008 | Year | 07 | Month | 07 | Day |
Date of IRB
| 2008 | Year | 09 | Month | 09 | Day |
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
| 2022 | Year | 08 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001770
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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