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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000010922
Receipt No. R000012780
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
Date of disclosure of the study information 2013/06/11
Last modified on 2019/06/16

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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/ctr_e/ctr_view.cgi?recptno=R000012780

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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