臨床研究等提出・公開システム

Date of registration	May. 17, 2022
Last modified on	May. 17, 2022
Trial ID	jRCT1030220064

Scientific Title	An observational study to investigate outcomes and post-treatment status after completion of study treatment in patients who participated in the investigator-initiated "Trastuzumab combIned with pertuzumab for patients with HER2 positive mCRC (TRIUMPH Study)"
Public Title	TRIUMPH Observational Study

Contact for Scientific Queries	Name	Nakamura Yoshiaki
	Affiliation	National Cancer Center Hospital East
	Address	6-5-1 Kashiwanoha, Kashiwa-shi, Chiba
	Telephone	+81-4-7133-1111
	E-mail	triumph_core@east.ncc.go.jp
Contact for Public Queries	Name	Nakamura Yoshiaki
	Affiliation	National Cancer Center Hospital East
	Address	6-5-1 Kashiwanoha, Kashiwa-shi, Chiba
	Telephone	+81-4-7133-1111
	E-mail	triumph_core@east.ncc.go.jp

Recruitment status	Not Recruiting

Anticipated date of first enrollment		July. 01, 2022
Target sample size		30
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion Criteria	All patients who participated in the TRIUMPH study
	Exclusion Criteria	Patients withdrawing consent for the TRIUMPH trial as of the end of April 2022
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Patients with HER2 positive mCRC
Primary Outcome(s)		Overall survival
Secondary Outcome(s)		Progression-free survival Duration of response Time to treatment failure

Primary Sponsor	National Cancer Center Hospital East

Name of Certified Review Board	National Cancer Center IRB
Address	5-1-1 Tsukiji, Chuo-ku, Tokyo
Telephone	+81-3-3542-2511
E-Mail	NCC_IRBoffice@ml.res.ncc.go.jp
Approval Status	Approval
Date of approval	Feb. 24, 2022

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none