臨床研究等提出・公開システム

Date of registration	Oct. 25, 2010
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080221282

Scientific Title	A Phase I Study of DE-766 with Concurrent Chemoradiotherapy in Patients with Locally Advanced Esophageal Cancer
Public Title

Completion Date or Terminated date
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD
Plan description
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries
	Address
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	DAIICHI SANKYO Co.,Ltd.
	Address	http://www.daiichisankyo.co.jp/corporate/rd/measure/clinical/index.html
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size		20
Study Type		Interventional
Study Design	Study Design	Multi-center, open-label
Study Design	Objective
Phase		1
Key inclusion & exclusion criteria	Inclusion Criteria	Patients with stage II, III (non-T4), or IV (non-T4 and M1 lymph nodes) esophageal cancer, who considered suitable to undergo definitive radiotherapy Patients without a history of esophageal cancer treatment and without a history of previous treatment of other malignant tumors
	Exclusion Criteria	Patients with another active malignancy Patients with severe esophageal stenosis or esophago-mediastinal fistula Patients with any of the severe or uncontrolled complications
	Minimum Age	20age old over
	Maximum Age	74age old under
	Gender	Both
Health Condition or Problem Studied		Esophageal cancer
Intervention(s)		investigational material(s) Generic name etc : DE-766 INN of investigational material : nimotuzumab Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Intravenous infusion
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Dose limiting toxicity and maximum tolerated dose CTCAE(Ver.4.0)
Secondary Outcome		Adverse events, pharmacokinetic, anti-tumor effects, complete response rate, progression-free survival, overall survival rate CTCAE(Ver.4.0), RECIST(Ver.1.1)

Primary Sponsor	DAIICHISANKYO Co.,Ltd.
Secondary Sponsor

Name of Funding Organization
Name of Research Funding

Name of IRB
Address of IRB
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review
Date of Approval by IRB

Secondary ID No.	JapicCTI-101319
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
11	Dec. 17, 2018	(this page)	Changes
10	June. 19, 2015	Detail	Changes
9	June. 19, 2015	Detail	Changes
8	Sept. 19, 2014	Detail	Changes
7	Sept. 19, 2014	Detail	Changes
6	Feb. 26, 2013	Detail	Changes
5	Feb. 26, 2013	Detail	Changes
4	Jan. 27, 2011	Detail	Changes
3	Jan. 27, 2011	Detail	Changes
2	Oct. 25, 2010	Detail	Changes
1	Oct. 25, 2010	Detail

List of change history