UMIN-CTR Clinical Trial

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
Email	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
Email	h-sato0808@hotmail.co.jp

Sponsor
Institute	Kanto Neurosurgical Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037487