UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032875 |
|---|---|
| Receipt number | R000037487 |
| Scientific Title | Feasibility study of radiotherapy using CyberKnife for metastatic lung tumors from adenoid cystic carcinoma |
| Date of disclosure of the study information | 2018/07/01 |
| Last modified on | 2021/06/07 09:51:31 |
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Basic information
Public title
Feasibility study of radiotherapy using CyberKnife for metastatic lung tumors from adenoid cystic carcinoma
Acronym
Feasibility study of radiotherapy using CyberKnife for metastatic lung tumors from adenoid cystic carcinoma
Scientific Title
Feasibility study of radiotherapy using CyberKnife for metastatic lung tumors from adenoid cystic carcinoma
Scientific Title:Acronym
Feasibility study of radiotherapy using CyberKnife for metastatic lung tumors from adenoid cystic carcinoma
Region
| Japan |
Condition
Condition
metastatic lung tumors from adenoid cystic carcinoma
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of radiotherapy using CyberKnife for metastatic lung tumors from adenoid cystic carcinoma
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Toxicity
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 12 | years-old | <= |
Age-upper limit
| 95 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) diagnosed as metastatic lung tumors from adenoid cystic carcinoma in clinical course
2) measurable tumors
3) a performance status of 0-2
Key exclusion criteria
The presence of other primary cancers
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Tsuneo |
| Middle name | |
| Last name | Shimizu |
Organization
Kanto Neurosurgical Hospital
Division name
Cyber Center
Zip code
360-0804
Address
1120, Dai, Kumagaya, Saitama 360-0804 JAPAN
TEL
048-521-3133
kantou@ps.ksky.ne.jp
Public contact
Name of contact person
| 1st name | Hiro |
| Middle name | |
| Last name | Sato |
Organization
Gunma University Graduate School of Medicine
Division name
Department of Radiation Oncology
Zip code
371-8511
Address
3-39-22 Showa-machi, Maebashi, Gunma 371-8511 JAPAN
TEL
027-220-8383
Homepage URL
h-sato0808@hotmail.co.jp
Sponsor or person
Institute
Kanto Neurosurgical Hospital
Institute
Department
Personal name
Funding Source
Organization
Kanto Neurosurgical Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kanto Neurosurgical Hospital
Address
1120, Dai, Kumagaya, Saitama 360-0804 JAPAN
Tel
048-521-3133
kantou@ps.ksky.ne.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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/33838695/
Publication of results
Partially published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/33838695/
Number of participants that the trial has enrolled
1
Results
The patient underwent SBRT at 60 Gy in 10 sequential fractions for each tumor. The biologically effective dose based on an alpha/beta ratio of 2 Gy was 240 Gy per tumor. The percentage of the total lung volume irradiated with >20 Gy was 4.9%, 3.2%, and 2.6% for each tumor.
Results date posted
| 2021 | Year | 06 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A 76-year-old Japanese man with ACC who was treated with carbon ion radiotherapy for a primary oropharynx tumor presented with three metastatic lesions in the lung.
Participant flow
The total dose was 64 Gy (relative biological effectiveness) delivered in 16 fractions. After 30 months, there was no recurrence of the primary lesion; however, the metastatic lung tumors had increased in size.
Adverse events
The patient developed acute radiation pneumonitis during the initial therapy, which resolved at 6 months after the CyberKnife treatment. At 21 months after the first CyberKnife treatment, three tumors showed no signs of recurrence. No late toxicity was observed.
Outcome measures
The patient underwent SBRT at 60 Gy in 10 sequential fractions for each tumor. The biologically effective dose based on an alpha/beta ratio of 2 Gy was 240 Gy per tumor. The percentage of the total lung volume irradiated with >20 Gy was 4.9%, 3.2%, and 2.6% for each tumor.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2018 | Year | 06 | Month | 05 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 05 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 07 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 25 | Day |
Date of closure to data entry
| 2019 | Year | 12 | Month | 25 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
1) diagnosed as metastatic lung tumors from adenoid cystic carcinoma in clinical course
2) measurable tumors
3) a performance status of 0-2
Management information
Registered date
| 2018 | Year | 06 | Month | 05 | Day |
Last modified on
| 2021 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037487
