UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of Neoadjuvant chemotherapy with Gemcitabine and S1 (GS therapy) for resectable pancreatic carcinoma (NAC GS2+2)
Title of the study (Brief title)	Phase II study of Neoadjuvant chemotherapy with Gemcitabine and S1 (GS therapy) for resectable pancreatic carcinoma (NAC GS2+2)
Region	Japan

Condition
Condition	resectable pancreatic cancer
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and feasibilty for gemcitabine and S1 therapy as Neoadjuvant against pancreatic cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	True R0 resection rate; The rate of R0 resection with the normalized post-operative tumor markers
Key secondary outcomes	Adverse effect, pathological effect, recurrence free survival, overall survival, patterns of recurrence, reduction rate and normalization rate for tumor marker

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Neoadjuvant chemotherapy with gemcitabine and S1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) invasive ductal carcinoma of the pancreas 2) no distant metastasis 3) R0/1 resectable 4) all adult who anticipate to undergo pancreatectomy 5) no prior therapy 6) written informed consent
Key exclusion criteria	1) pulmonary fibrosis or interstitial pneumonitis 2) tumor other than ductal carcinoma 3) distant metastasis 4) R2 resection 5) prior anti-cnacer therapy 6) pregnancy 7) under 18 years old
Target sample size	35

Research contact person
Name of lead principal investigator	Michiaki Unno
Organization	Tohoku University Graduate School of Medicine
Division name	Gastroenterological Surgery
Address	1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan
TEL	022-717-7205
Email	m_unno@surg1.med.tohoku.ac.jp

Public contact
Name of contact person	Kei Nakagawa
Organization	NEXTSURG
Division name	Coordinating office
Address	1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan
TEL	022-343-9234
Homepage URL	http://nextsurg.kenkyuukai.jp/about/
Email	kein_h11@surg1.med.tohoku.ac.jp

Sponsor
Institute	NEXTSURG
Institute
Department

Funding Source
Organization	None (Self-funding)
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2012 Year 10 Month 15 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2012 Year 08 Month 24 Day
Anticipated trial start date	2012 Year 10 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 10 Month 09 Day
Last modified on	2017 Year 10 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010488