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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	JPRN
Last refreshed on:	17 October 2023
Main ID:	JPRN-UMIN000024695
Date of registration:	04/11/2016
Prospective Registration:	Yes
Primary sponsor:	National Institutes for Quantum and Radiological Science and Technology
Public title:	A clinical trial for efficacy and safety on carbon-ion radiotherapy and concurrent GEM chemotherapy for locally advanced pancreatic cancer
Scientific title:	A clinical trial for efficacy and safety on carbon-ion radiotherapy and concurrent GEM chemotherapy for locally advanced pancreatic cancer - Carbon-ion radiotherapy and GEM for locallyadvanced pancreatic cancer
Date of first enrolment:	2016/12/19
Target sample size:	82
Recruitment status:	Complete: follow-up complete
URL:	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028401
Study type:	Interventional
Study design:	Single arm Non-randomized
Phase:	Phase II

Countries of recruitment
Japan

Contacts

Name:	Shigeru Yamada
Address:	4-9-1Anagawa, Inageku, Chiba Japan
Telephone:	043-206-3306
Email:	kamada.tadashi@qst.go.jp
Affiliation:	National Institutes for Quantum and Radiological Science and Technology National Institutes for Radiological Science

Name:	Shigeru Yamada
Address:	4-9-1Anagawa, Inageku, Chiba 263-8555 Japan
Telephone:	043-206-3306
Email:	yamada.shigeru@qst.go.jp
Affiliation:	National Institutes for Quantum and Radiological Science and Technology QST Hospital

Key inclusion & exclusion criteria

Inclusion criteria:
Exclusion criteria: 1 Invasion of the mucosal layer by endoscopic diagnosis 2.displacement of digestive tracts by Radiographic diagnosis 3 Ascites by Radiographic diagnosis 4.Placement of a metal stent for relief of biliary obstruction 5. Prior treatment for pancreatic cancer for longer than 90days

Age minimum: 20years-old
Age maximum: 80years-old
Gender: Male and Female

Health Condition(s) or Problem(s) studied

Locally advanced pancreatic cancer

Intervention(s)

Carbon-ion 55.2Gy(RBE)/12fraction/3weeks+ Gemcitabine 1000mg/m2 X 3times

Primary Outcome(s)

2-year overall survival rate

Secondary Outcome(s)

Secondary ID(s)

J-CROS 1502 Pancreas

Source(s) of Monetary Support

National Institutes for Quantum and Radiological Science and Technology

Secondary Sponsor(s)

Clinical Research Center, Chiba University Hospital

Ethics review

Status: YES
Approval date: 27/11/2015
Contact:

helsinki@qst.go.jp

National Institute of Radiological Sciences Certified Review Board

043-206-4706

helsinki@qst.go.jp

Results

Results available:	Yes
Date Posted:
Date Completed:	30/09/2023
URL:

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