UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016547 |
|---|---|
| Receipt number | R000019146 |
| Scientific Title | A multi-institutional phase II study on safety and efficacy of dynamic tumor tracking stereotactic radiotherapy for the lung |
| Date of disclosure of the study information | 2015/05/01 |
| Last modified on | 2022/08/22 17:00:00 |
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Basic information
Public title
A multi-institutional phase II study on safety and efficacy of dynamic tumor tracking stereotactic radiotherapy for the lung
Acronym
Phase II study on lung DT-SBRT
Scientific Title
A multi-institutional phase II study on safety and efficacy of dynamic tumor tracking stereotactic radiotherapy for the lung
Scientific Title:Acronym
Phase II study on lung DT-SBRT
Region
| Japan |
Condition
Condition
Lung cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of dynamic tumor tracking stereotactic radiotherapy for lung cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
2-year local control rate
Key secondary outcomes
Overall survival, progression-free survival, local progression-free survival, adverse event, severe adverse event, accuracy in the treatment, dose-volume metrics
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
| Device,equipment | Other |
Interventions/Control_1
Dynamic tumor tracking radiotherapy using Vero4DRT
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) primary or metastatic lung cancer which satisfies the following conditions:
Primary lung cancer
(1)
(a) pathological or cytological diagnosis of primary lung cancer
(b) clinically diagnosed primary lung cancer with a consensus of multiple doctors based on tumor marker, CT, FDG-PET, etc.
(2) tumor diameter of 5cm or less and clinical stage of IA-IB diagnosed with imaging studies
Metastatic lung cancer
(1) clinically diagnosed metastatic lung cancer
(2) three or less tumors with diameters of 5cm or less without any extrapulmonary lesions which was diagnosed with imaging studies
2) Ineligibility to standard surgery confirmed by institutional thoracic surgeons, or patient's refusal of surgery
3) Predicted to satisfy dose constraints for the surrounding organ
4) Aged 20 years or more
5) ECOG-PS of 0 to 2
6) Able to keep the patient's position with the arms raised for 30 mins or more
7) Respiratory motion of 10 mm or more
Key exclusion criteria
1) history of radiotherapy to the same area
2) active interstitial pneumonia or pulmonary fibrosis
3) severe diabetes mellitus or collagen disease
4) female who are pregnant or in lactation
5) metal disease which prevents registration of the study
6) other issues which are considered to be inappropriate for the study by the doctors
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Mizowaki |
Organization
Kyoto University
Division name
Dept of Radiation Oncology and Image-applied Therapy, Graduate School of Medicine
Zip code
606-8507
Address
54, Shogoinkawaharacho, Sakyo, Kyoto
TEL
075-751-3417
mizo@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Yukinori |
| Middle name | |
| Last name | Matsuo |
Organization
Kyoto University
Division name
Dept of Radiation Oncology and Image-applied Therapy, Graduate School of Medicine
Zip code
606-8507
Address
54, Shogoinkawaharacho, Sakyo, Kyoto
TEL
075-751-3762
Homepage URL
ymatsuo@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
AMED
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee
Address
Yoshida Konoe cho, Sakyo, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-u.ac.jp
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
京都大学医学部附属病院（京都府）、先端医療センター病院（兵庫県）、がん・感染症センター都立駒込病院（東京都）、京都桂病院（京都府）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019146
Publication of results
Partially published
Result
URL related to results and publications
https://doi.org/10.1016/j.radonc.2022.04.028
Number of participants that the trial has enrolled
48
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 05 | Month | 02 | Day |
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
| 2015 | Year | 04 | Month | 23 | Day |
Date of IRB
| 2015 | Year | 04 | Month | 23 | Day |
Anticipated trial start date
| 2015 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 02 | Month | 16 | Day |
Last modified on
| 2022 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019146
| Research Plan | |
|---|---|
| Registered date | File name |
| 2022/08/30 | AMED肺追尾観察研究ver1.0.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2022/08/30 | AMED追尾観察研究CRF.docx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2023/02/06 | AMED追尾多施設（肺）20230206fin.xlsx |
