臨床研究等提出・公開システム

Scientific Title	A clinical study to evaluate the feasibility and dose delivery accuracy of modified track Dynamic WaveArc therapy
Public Title	A clinical study to evaluate the feasibility and dose delivery accuracy of modified track Dynamic WaveArc therapy

Completion date	Mar. 23, 2022
Result actual enrolment	25
Baseline Characteristics	Breast cancer APBI 12 cases, Vertebral SBRT 13cases
Participant flow	The planned enrollment was 25 patients, withthe first patient enrolled on August 19, 2020, and the 25th patient enrolled on December 24, 2021.
Adverse events	Pain Grade 2 was observed in one patient as an expected adverse event. All other cases were Grade 1 or less. No unanticipated adverse events were observed. No serious adverse events were observed.
Outcome measures	The primary endpoint, protocol completion rate, was 100%. Secondary endpoints, which require long-term follow-up, will be reported later.
Brief summary	To evaluate the feasibility of variable trajectory DWA, a novel irradiation technique using Vero4DRT, a clinical trial was conducted for breast APBI and spinal SBRT. 25 patients (12 APBI, 13 spinal SBRT) were enrolled and treated with variable trajectory DWA. All patients were able to complete the planned treatment, and the primary endpoint, protocol completion rate, was 100%.
Date of posting of results summaries	April. 28, 2022
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD	No
Plan description
URL link to protocol file(s) with version and date	https://jrct.mhlw.go.jp/latest-detail/jRCT1052200034

Contact for Scientific Queries	Name	Mizowaki Takashi
	Affiliation	Kyoto University Hospital
	Address	54, Shogoin Kawahara-cho, Sakyo-ku, Kyoto-shi, KYOTO
	Telephone	+81-75-751-3762
	E-mail	mizo@kuhp.kyoto-u.ac.jp
Contact for Public Queries	Name	Nakamura Kiyonao
	Affiliation	Kyoto University Hospital
	Address	54, Shogoin Kawahara-cho, Sakyo-ku, Kyoto-shi, KYOTO
	Telephone	+81-75-751-3762
	E-mail	kiyonaka@kuhp.kyoto-u.ac.jp

Recruitment status	Complete

Anticipated date of first enrollment		July. 08, 2020
Actual date of first enrollment		Aug. 19, 2020
Target sample size		25
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Left breast cancer, post surgery. spinal metastases less than 3 lesions.
	Exclusion Criteria	Severe complications. Mental illness. Re-irradiation. Dose distribution of DWA is inferior to conventional radiotherapy
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Breast cancer (left), Spinal metastases
Intervention(s)		Radiotherpy with Dynamic Wave-arc method.
Health Condition(s) Keyword		APBI, Spinal metastasis
Intervention(s) Keyword		high-precision radiotherapy
Health Condition(s) Code		D001943, D009362
Intervention(s) Code		D011878
Primary Outcome(s)		Completion of treatment protocol
Secondary Outcome(s)		Breast cancer : acute adverse event rate, late adverse event rate, recurrence-free survival in affected breast, breast aggravation, deterioration of breast cosmetic outcomes rate, disease-free survival, overall survival Spinal metastases : acute adverse event rate, late adverse event rate, local progression-free survival, recurrence-free survival, overall survival

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support	Japan Agency for Medical Research and development
Secondary Sponsor	Not applicable

Name of Certified Review Board	Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address	Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN, Kyoto
Telephone	+81-75-753-4680
E-Mail	ethcom@kuhp.kyoto-u.ac.jp
Approval Status	Approval
Date of approval	June. 17, 2020

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

List of change history