UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006172 |
|---|---|
| Receipt number | R000006920 |
| Scientific Title | Feasibility study of dose eslation and concentration in stereotactic body radiotherapy (SBRT) for lung tumors |
| Date of disclosure of the study information | 2011/08/16 |
| Last modified on | 2015/01/13 14:13:10 |
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Basic information
Public title
Feasibility study of dose eslation and concentration in stereotactic body radiotherapy (SBRT) for lung tumors
Acronym
Feasibility study of dose eslation and concentration in SBRT for lung tumors
Scientific Title
Feasibility study of dose eslation and concentration in stereotactic body radiotherapy (SBRT) for lung tumors
Scientific Title:Acronym
Feasibility study of dose eslation and concentration in SBRT for lung tumors
Region
| Japan |
Condition
Condition
T1-4N0M0 non-small cell lung cancer
solitary or ipsilateral two lung metastasis
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of SBRT for lung tumor with the dose prescription of 60Gy per 5 fraction (60% isodose) (phase I study)
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
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
incidence of Grade 3 or more radiation pneumonitis, adverse events, severe adverse events, local progression free survival, 3-year local progression free survival, event free survival
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
1-1.Histologically or cytologically (class IV or V) diagnosed NSCLC or solitary or ipsilateral two lung metastasis
1-2.radiographically diagnosed NSCLC (with no elevation of NSE or proGRP) or solitary or ipsilateral two lung metastasis
2.CT diagnosis within 60 days and FDG-PET diagnosis within 90 days
3.No other intrathoracic lesions
4.Dose constraints of the organs at risk seem to be limited within range
5.No previous thoracic radiation
6.No previous chemotherapy
7.ECOG PS=0-2
8.GOLD stage 0-II
9.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
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsuya Takeda |
Organization
Ofuna Chuo Hospital
Division name
Department of Radiology
Zip code
Address
6-2-24 Ofuna, Kamakura-City, Kanagawa, 247-0056 Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Ofuna Chuo Hospital
Division name
Department of Radiology
Zip code
Address
TEL
Homepage URL
takeda@1994.jukuin.keio.ac.jp
Sponsor or person
Institute
Ofuna SBRT study group
Institute
Department
Personal name
Funding Source
Organization
Ofuna SBRT study group
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 08 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/24833770
Number of participants that the trial has enrolled
Results
The median follow-up duration was 22.0 (12.0-27.0) months. After 6 months post-SBRT, the respective number of RP Grade 0, 1 and 2 cases was 5, 9 and 1. In the Grade 2 RP patient, the image showed an organizing pneumonia pattern at 6.0 months post-SBRT. No other toxicity was found. At last follow-up, there was no evidence of recurrence of the treated tumors.
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
| 2011 | Year | 08 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 08 | Month | 15 | Day |
Last modified on
| 2015 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006920
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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