臨床研究等提出・公開システム

Japanese

Date of registration	Oct. 26, 2022
Last modified on	Sept. 25, 2024
Trial ID	jRCT2031220410

Scientific Title	A phase II study of boron neutron capture therapy (BNCT) for patients with unresectable angiosarcoma, by using CICS-1 and SPM-011
Public Title	A phase II study by using CICS-1 and SPM-011 commissioned by CICS and STELLA PHARMA

Contact for Scientific Queries	Name	Hayashi Toshimitsu
	Affiliation	STELLA PHARMA CORPORATION
	Address	ORIX Kouraibashi Building, 3-2-7 Kouraibashi, Chuo-ku, Osaka
	Telephone	+81-6-4707-1516
	E-mail	sp-chiken@stella-pharma.co.jp
Contact for Public Queries	Name	Clinical trials information
	Affiliation	Stella Pharma Corporation
	Address	ORIX Kouraibashi Building, 3-2-7 Kouraibashi, Chuo-ku, Osaka
	Telephone	+81-6-4707-1516
	E-mail	sp-chiken@stella-pharma.co.jp

Recruitment status	Not Recruiting

Anticipated date of first enrollment		Nov. 01, 2022
Actual date of first enrollment		Jan. 19, 2023
Target sample size		10
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	- Written informed consent must be obtained from the subject. - Histologically documented primary skin angiosarcoma. - Locally advanced or locally recurrent angiosarcoma, and not eligible for curative surgery, chemoradiotherapy or radiotherapy. (Including cases where the individual refuses treatment.) - Measurable disease, as defined by RECIST v1.1. - The longest diameter of the entire target lesion is 15 cm or less. - ECOG performance status score of Grade 0 to 2
	Exclusion Criteria	- Apparent disseminated tumor lesions. - Hereditary fructose intolerance. - Phenylketonuria. - Any serious concomitant disease that precludes completion of the study treatment. - The target lesion has received radiation exceeding 75 Gy.
	Age Minimum	18age old over
	Age Maximum	89age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Unresectable angiosarcoma
Intervention(s)		SPM-011 (JAN:Borofalan (10B)) is administered intravenously at a rate of 200 mg/kg per hour for 2 hours. The irradiation of the target lesion with neutron beams is then initiated, and SPM-011 is administered intravenously at a rate of 100 mg/kg per hour during irradiation.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Response rate (RECIST v1.1)
Secondary Outcome(s)

Primary Sponsor	Stella Pharma Corporation

Primary Sponsor	Cancer Intelligence Care Systems, Inc.

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	National Cancer Center Institutional Review Board
Address	5-1-1 Tsukiji, Chuo-ku, Tokyo, Tokyo
Telephone	+81-3-3542-2511
E-Mail	Chiken_CT@ml.res.ncc.go.jp
Approval Status	Approval
Date of approval	Oct. 28, 2022

Plan to share IPD	No
Plan description

Secondary ID(s)	NCT05601232
Issuing Authority	ClinicalTrials.gov

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
5	Sept. 25, 2024	(this page)	Changes
4	April. 05, 2024	Detail	Changes
3	Nov. 25, 2023	Detail	Changes
2	Nov. 28, 2022	Detail	Changes
1	Oct. 26, 2022	Detail

List of change history