UMIN-CTR Clinical Trial

Basic information
Public title	Randomized phase II trial of chemoradiotherapy with S-1 versus gemcitabine and S-1 combination therapy as neoadjuvant treatment in patients with resecatble pancreatic cancer
Acronym	Randomized phase II trial of chemoradiotherapy with S-1 versus gemcitabine and S-1 combination therapy as neoadjuvant treatment in patients with resecatble pancreatic cancer (JASPAC 04)
Scientific Title	Randomized phase II trial of chemoradiotherapy with S-1 versus gemcitabine and S-1 combination therapy as neoadjuvant treatment in patients with resecatble pancreatic cancer
Scientific Title:Acronym	Randomized phase II trial of chemoradiotherapy with S-1 versus gemcitabine and S-1 combination therapy as neoadjuvant treatment in patients with resecatble pancreatic cancer (JASPAC 04)
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the efficacy and safety of chemoradiotherapy with S-1 or gemcitabine and S-1 combination therapy as neoadjuvant treatment in patients with resectable pancreatic cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase II

Assessment
Primary outcomes	2-year progression-free survival
Key secondary outcomes	overall survaival (2-year survival rate), R0 or 1 resection rate, pathological response rate, adverse event of neoadjuvant therapy, morbidity rate of surgery, non-hematologic adverse event of grade 4, early mortality rate, treatment-related mortality rate

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine Maneuver
Interventions/Control_1	chemoradiotherapy with S-1 as neoadjuvant treatment
Interventions/Control_2	Gemcitabine and S-1 combination therapy as neoadjuvant treatment
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	79 years-old >=
Gender	Male and Female
Key inclusion criteria	1 Invasive ductal adenocarcinoma of the pancreas based on the images, 2 Adenocarcinoma is proven by biopsy or cytology, 3 Radiation field for the primary lesion and lymph node metastasis is lemited within 10 cm, 4 No gastric or duodenal ulcer 5 No cancerous invasion into stomach or duodenum, etc
Key exclusion criteria	1 Treatment history with gemcitabine or fuluoruracil, 2 Use of flucytosine, phenytoin, and warfarin potassium, 3 Fibroid lung or interstitial pneumonia, 4 Pleural lung or ascites 5 Watery diarrhea, etc
Target sample size	100

Research contact person
Name of lead principal investigator	1st name KATSUHIKO Middle name Last name UESAKA
Organization	Shizuoka Cancer Center Hospital
Division name	Division of Hepato-Biliary-Pancreatic Surgery
Zip code	411-8777
Address	1007, Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777 JAPAN
TEL	055-989-5222
Email	k.uesaka@scchr.jp

Public contact
Name of contact person	1st name KATSUHIKO Middle name Last name UESAKA
Organization	Shizuoka Cancer Center Hospital
Division name	Division of Hepato-Biliary-Pancreatic Surgery
Zip code	411-8777
Address	1007, Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777 JAPAN
TEL	055-989-5222
Homepage URL
Email	k.uesaka@scchr.jp

Sponsor
Institute	Japan Adjuvant Study Group of Pancreatic Cancer (JASPAC)
Institute
Department

Funding Source
Organization	Shizuoka Organization for Creation of Industries, Pharma Valley Center
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	Institutional Review Board, Shizuoka Cancer Center
Address	1007, Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777 JAPAN
Tel	055-989-5222
Email	k.goto@scchr.jp

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	静岡県立静岡がんセンター (Shizuoka Cancer Center Hospital)、他(etc)

Other administrative information
Date of disclosure of the study information	2014 Year 08 Month 19 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	103
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2012 Year 02 Month 14 Day
Date of IRB	2013 Year 03 Month 26 Day
Anticipated trial start date	2013 Year 05 Month 01 Day
Last follow-up date	2019 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 08 Month 19 Day
Last modified on	2020 Year 02 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015533