UMIN-CTR Clinical Trial

Basic information
Public title	Randomized phase II study with S-1 (4week treatment and 2week rest) or S-1 (Alternate day administration) adjuvant chemotherapy for patients with pancreatic cancer
Acronym	HORE PC01
Scientific Title	Randomized phase II study with S-1 (4week treatment and 2week rest) or S-1 (Alternate day administration) adjuvant chemotherapy for patients with pancreatic cancer
Scientific Title:Acronym	HORE PC01
Region	Japan

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

Objectives
Narrative objectives1	To demonstrate the clinical effectiveness of the S-1 (4week treatment and 2week rest) or S-1 (Alternate day administration) adjuvant chemotherapy for the patients with pancreatic cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	treatment complete rate
Key secondary outcomes	Relapse free survival, overall survival, Safety

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
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	S-1by Alternate day administration for 180days (6months) (1 course=6weeks, 42days).
Interventions/Control_2	S-1 for 28 days with 14 days rest for 180days (6months) (1 course=6weeks, 42days).
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) Resected cases with histologically proven invasive ductal carcinoma of the pancreas 2) According to the UICC classification, a) Stage I or II, or III in whom celiac artery resection was performed b) R0 or R1 c) Cancer negative for washing cytology of the abdominal cavity 3) No distant metastasis nor malignant ascites 4) Adequate oral intakes 5) Aged 20 years or older 6) An Eastern Cooperative Oncology Group performance status of 0 or 1 7) No prior history of chemotherapy nor radiation therapy within three years 8) Within 10 weeks after operation 9) Sufficient organ function 10) Written informed consent
Key exclusion criteria	1) Prior history of S-1 therapy 2) Recurrent disease on enrollment 3) Massive ascites or pleural effusion 4) Plumonary fibrosis or interstitial pneumonia 5) Severe diarrhea 6) Severe infection 7) Blood transfusion within two weeks 8) Other severe complications such as heart failure, renal failure, liver failure, peptic ulcer, intestinal paralysis, etc 9) Severe mental disorder 10) Severe drug allergy 11) Other active malignancy 12) Pregnancy, breast feeding, or women who desire to preserve fecundity or Men who desire to have children 13) Regular use of frucitocin, fenitoin or warfarin 14) Inadequate physical condition, as diagnosed by primary physician
Target sample size	70

Research contact person
Name of lead principal investigator	1st name Hiroyuki Middle name Last name Konno
Organization	Hamamatsu University School of Medicine
Division name	Second Department of Surgery
Zip code	431-3192
Address	1-20-1, Handayama Hamamatsu Shizuoka 431-3192, Japan
TEL	053-435-2279
Email	kon_6416@hama-med.ac.jp

Public contact
Name of contact person	1st name Takanori Middle name Last name Sakaguchi
Organization	Hamamatsu University School of Medicine
Division name	Second Department of Surgery
Zip code	431-3192
Address	1-20-1, Handayama Hamamatsu Shizuoka 431-3192, Japan
TEL	053-435-2279
Homepage URL
Email	saka1119@hama-med.ac.jp

Sponsor
Institute	HORE
Institute
Department

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

Other related organizations
Co-sponsor	iwata city hospital Hamamatsu medical center shizuoka city shimizu hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Hamamatsu University School of Medicine
Address	1-20-1, Handayama Hamamatsu Shizuoka 431-3192
Tel	053-435-2111
Email	rinri@hama-med.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	静岡

Other administrative information
Date of disclosure of the study information	2013 Year 06 Month 11 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
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	Open public recruiting
Date of protocol fixation	2013 Year 05 Month 31 Day
Date of IRB	2013 Year 04 Month 01 Day
Anticipated trial start date	2013 Year 06 Month 01 Day
Last follow-up date	2018 Year 12 Month 31 Day
Date of closure to data entry	2018 Year 12 Month 31 Day
Date trial data considered complete	2018 Year 12 Month 31 Day
Date analysis concluded	2018 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date	2013 Year 06 Month 10 Day
Last modified on	2019 Year 06 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012780