UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase I/II study of Gemcitabine and S-1 (GS therapy) as Neoadjuvant chemoradiationtherapy for borderline resectable pancreatic cancer (Prep-03/NS014-1)
Title of the study (Brief title)	Neoadjuvant GS chemoradationtherapy for borderline resectable pancreatic cancer : Prep-03/NS014-1
Region	Japan

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

Objectives
Narrative objectives1	Phase I: To establish the recommended doserecommended dose for neoadjuvant GS radiation therapy. Phase II: To evaluate the equivalence of safety and resection rate for neoadjuvant GS radiation therapy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I,II

Assessment
Primary outcomes	Phase I:Maximum Tolerated Dose, Recommended Dose Phase II: R0 resection rate
Key secondary outcomes

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 Other
Interventions/Control_1	Neoadjuvant chemoradiationtherapy withgemcitabine and S-1 followed by surgery.
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	20 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) borderline resectable Pancreatic cancer 5) all adult who anticipate to undergo pancreatectomy 6) no prior therapy 7) ECOG performance status of 0 or 1 8) adequate organ function 9) oral intake is possible 10) written informed consent
Key exclusion criteria	1) pulmonary fibrosis or interstitial pneumonitis 2) Active double cancer 3) Active infection 4) HBs antigen positive 5) patients are using flucytosine, phenytoin, warfarin 6) pregnant females, possibly pregnant females
Target sample size	40

Research contact person
Name of lead principal investigator	Michiaki Unno
Organization	Tohoku University Graduate School of Medicine
Division name	Division of Surgery
Address	1-1, Seiryo-machi, Aoba-ku, Sendai, Japan
TEL	022-717-7205
Email	kein_h11@surg1.med.tohoku.ac.jp

Public contact
Name of contact person	Kei Nakagawa
Organization	Tohoku University Graduate School of Medicine
Division name	Division of Integrated Surgery and Oncology
Address	1-1, Seiryo-machi, Aoba-ku, Sendai, Japan
TEL	022-717-7205
Homepage URL
Email	kein_h11@surg1.med.tohoku.ac.jp

Sponsor
Institute	Study group of preoperative therapy for pancreatic cancer (PREP)
Institute
Department

Funding Source
Organization	Study group of preoperative therapy for pancreatic cancer (PREP)
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	2014 Year 07 Month 07 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2014 Year 06 Month 19 Day
Anticipated trial start date	2014 Year 08 Month 04 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	2014 Year 07 Month 07 Day
Last modified on	2017 Year 07 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016075