UMIN-CTR Clinical Trial

Basic information
Public title	Neoadjuvant S-1 therapy for resectable pancreatic cancer patients; A phase2 study
Acronym	HOPS-R01
Scientific Title	Neoadjuvant S-1 therapy for resectable pancreatic cancer patients; A phase2 study
Scientific Title:Acronym	HOPS-R01
Region	Japan

Condition
Condition	pancreatic cancer
Classification by specialty	Hepato-biliary-pancreatic medicine Hematology and clinical oncology Hepato-biliary-pancreatic surgery Operative medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To verify the safety and the efficacy of neoadjuvant S-1 therapy for resectable pancreatic cancer patients
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Two year progression free survival
Key secondary outcomes	Two year overall survival, Resection rate, Pathological effect, Response rate, Adverse effect, Surgical complication

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	S-1:80mg/day(BSA<1.25/m2) 100mg/day(1.25/m2=<BSA<1.5/m2) 120mg/day(BSA=>1.5/m2), day1-28. 1 cycle 6weeks, repeat 2 cycles before 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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Pathologically or cytologically proven diagnosis of pancreas cancer. 2) Definition of a Resectable pancreatic cancer is filled in NCCN guidelines 2012 pancreatic adenocarcinoma 3) Without distant metastasis 4) Patients of age =>20 5) Performance Status:0-1 (ECOG) 6) Adequate oral intake 7) Good main organ function 8) Written informed consent
Key exclusion criteria	1) Treatment history of S-1 2) Treatment history of a pancreatic cancer 3) Regular use of frucitocin, fenitoin or warfarin 4) Patients who can' t receive neither iodic drug because of drug allergy 5) Lung fibrosis or intestinal pneumonia, and anamnesis or imaging findings 6) Massive pleural or abdominal effusion 7) Severe infection 8) Watery diarrhea 9) Uncontrolled diabetes 10) Simultaneous or metachronous (within 3 years) double cancers 11) Hemorrhagic peptic ulcer 12) Patients with severe disease 13) Patients requiring systemic steroids medication 14) Severe mental illness 15) Severe drug hypersensitivity 16)Pregnant females, possibly pregnant females, females wishing to become pregnant or Males that are currently attempting to produce a pregnancy 17)Patients seems inadequate for this study by investigators
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Satoshi Middle name Last name Hirano
Organization	Hokkaido University
Division name	Gastroenterological Surgery II
Zip code	060-8638
Address	N15, W7, Kita-ku, Sapporo, Hokkaido, Japan
TEL	011-706-7714
Email	satto@med.hokudai.ac.jp

Public contact
Name of contact person	1st name Toru Middle name Last name Nakamura
Organization	Hokkaido University
Division name	Gastroenterological Surgery II
Zip code	060-8638
Address	N15, W7, Kita-ku, Sapporo, Hokkaido, Japan
TEL	011-706-7714
Homepage URL
Email	torunakamura@med.hokudai.ac.jp

Sponsor
Institute	Hokkaido Pancreatic Cancer Study Group (HOPS)
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Institutional review board of Hokkaido University Hospital
Address	N14, W5, Kita-ku, Sapporo, Hokkaido, Japan
Tel	011-706-7636
Email	crjimu@huhp.hokudai.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	2014 Year 01 Month 31 Day

Related information
URL releasing protocol	http://www.huhp.hokudai.ac.jp/
Publication of results	Published

Result
URL related to results and publications	https://www.nature.com/articles/s41598-022-14094-0
Number of participants that the trial has enrolled	51
Results	2year disease free survival ITT(N=49):40.8% 2year disease free survival Resection(N=43):46.5% 2year overall survival ITT(N=49):73.2% 2year overall survival Resection(N=43):76.7%
Results date posted	2019 Year 03 Month 18 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Age(y.o):median 71(range 47-83) Gender(male/female):23/28 Pancreatic head/body:32/19
Participant flow	80 patients:Resectable over 20y.o., PS 0-1 51 patients:enrolled 49 patients:eligible 33 patients:operation 31 patients:resection
Adverse events	Grade 3/4, n (%) Hematological Anemia 1 (2.0) Leukopenia 2 (4.1) Neutropenia 4 (8.2) Thrombocytopenia 1 (2.0) Nonhematological 　 Fatigue 1 (2.0) Diarrhea 5 (10.2) Anorexia 2 (4.1) Nausea 2 (4.1) Vomiting 2 (4.1) Mucositis 0 Hyperpigmentation 0 Dermatitis 0 Cholangitis 3 (6.1) Pulmonary embolism 1 (2.0)
Outcome measures	2year disease free survival
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 10 Month 16 Day
Date of IRB	2013 Year 10 Month 16 Day
Anticipated trial start date	2013 Year 11 Month 01 Day
Last follow-up date	2018 Year 02 Month 28 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 01 Month 31 Day
Last modified on	2022 Year 09 Month 27 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015209