UMIN-CTR Clinical Trial

Basic information
Public title	Phase II/III study of Gemcitabine and S-1 (GS therapy) as Neoadjuvant chemotherapy for resectable pancreatic cancer (Prep-02/JSAP-05)
Acronym	Neoadjuvant GS therapy for pancreatic cancer : Prep-02/JSAP-05
Scientific Title	Phase II/III study of Gemcitabine and S-1 (GS therapy) as Neoadjuvant chemotherapy for resectable pancreatic cancer (Prep-02/JSAP-05)
Scientific Title:Acronym	Neoadjuvant GS therapy for pancreatic cancer : Prep-02/JSAP-05
Region	Japan

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

Objectives
Narrative objectives1	Phase II: To evaluate the equivalence of safety and resection rate for neoadjuvant GS therapy comparing standard therapy. Phase III: To evaluate superiority in survival of neoadjuvant GS therapy against standard surgery-first therapy in patients with resectable pancreatic cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II,III

Assessment
Primary outcomes	Phase II: Resection rate Phase III: Overall survival
Key secondary outcomes	Phase II: Adverse events Phase III: Adverse events, Resection rate, Residual tumor, Nodal involvement rate, Histological response, Relapse-free survival, Tumor marker kinetics, Dose intensity, Patterns of Recurrence, Radiological tumor response

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
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
Interventions/Control_1	Neoadjuvant chemotherapy with gemcitabine and S-1 followed by surgery and adjuvant with 4 course of oral S-1 (Test arm).
Interventions/Control_2	Surgery and adjuvant with 4 course of oral S-1 (Control arm).
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 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 6) ECOG performance status of 0 or 1 7) Adequate organ function 8) Written informed consent
Key exclusion criteria	1) pulmonary fibrosis or interstitial pneumonitis 2) Uncontrolled watery diarrhea 3) Active double cancer 4) Active infection 5) HBs antigen positive 6) Pregnant females, possibly pregnant females
Target sample size	360

Research contact person
Name of lead principal investigator	1st name Michiaki Middle name Last name Unno
Organization	Tohoku University Graduate School of Medicine
Division name	Division of gastroenterological surgery
Zip code	980-8574
Address	1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan
TEL	022-717-7205
Email	m_unno@surg.med.tohoku.ac.jp

Public contact
Name of contact person	1st name Fuyuhiko Middle name Last name Motoi
Organization	Tohoku University Graduate School of Medicine
Division name	Surgery
Zip code	980-8574
Address	1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan
TEL	022-717-7205
Homepage URL	http://www.surg.med.tohoku.ac.jp/society/prep02.html
Email	fmotoi@surg.med.tohoku.ac.jp

Sponsor
Institute	Study group of preoperative therapy for pancreatic cancer (PREP)/Japanese Study Group of Adjuvant Therapy for pancreatic Cancer (JSAP)
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	IRB of Tohoku Univ.
Address	1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan
Tel	022-717-8007
Email	rinri-2@proj.med.tohoku.ac.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

Other administrative information
Date of disclosure of the study information	2012 Year 12 Month 26 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	https://meetinglibrary.asco.org/record/169433/abstract
Number of participants that the trial has enrolled	364
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 12 Month 26 Day
Date of IRB	2012 Year 11 Month 27 Day
Anticipated trial start date	2013 Year 01 Month 04 Day
Last follow-up date	2019 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2012 Year 12 Month 26 Day
Last modified on	2019 Year 07 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010813