UMIN-CTR Clinical Trial

Basic information
Public title	Randomized phase III study of adjuvant chemotherapy with combination therapy of gemcitabine and S-1 vs. gemcitabine alone in patients with resected pancreatic cancer (JSAP-04)
Acronym	Phase III study of gemcitabine and S-1 combination therapy for resected pancreatic cancer
Scientific Title	Randomized phase III study of adjuvant chemotherapy with combination therapy of gemcitabine and S-1 vs. gemcitabine alone in patients with resected pancreatic cancer (JSAP-04)
Scientific Title:Acronym	Phase III study of gemcitabine and S-1 combination therapy for resected pancreatic cancer
Region	Japan

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

Objectives
Narrative objectives1	To evaluate superiority in survival of adjuvant chemotherapy with gemcitabine and S-1 against gemcitabine alone in patients with resected pancreatic cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase III

Assessment
Primary outcomes	Overall survival
Key secondary outcomes	Relapse-free survival Incidence of adverse events

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	Patients receive gemcitabine (1,000 mg/m2, days 1, 8 and 15) every 4 weeks. This cycle is repeated for six months or until relapse is confirmed.
Interventions/Control_2	Patients receive gemcitabine (800 mg/m2, day 1) plus S-1 (65 mg/m2/day, days 1-7) every 2 weeks. This cycle is repeated for six months or until relapse is confirmed.
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) Histologically proven invasive ductal carcinoma of the pancreas 2) Macroscopically curative resection (R0, R1) 3) No metastasis 4) No history of prior chemotherapy or radiotherapy for pancreatic cancer 5) Age 20 to 79 years 6) ECOG performance status of 0 or 1 7) Adequate organ function 8) Written informed consent 9) Within 10 weeks after surgery
Key exclusion criteria	1) History of serious complications related to surgery 2) Patients under treatment with phenytoin, warfarin potassium or flucytosine. 3) Uncontrolled watery diarrhea 4) Sever mental disorder 5) Active infection 6) Serious complications 7) Pulmonary fibrosis or interstitial pneumonia 8) Clinically significant pleural effusions or ascites 9) Active double cancer (synchronous double cancer or asynchronous double cancer with disease-free duration of 2 years or less) 10) History of chemotherapy or radiotherapy for other malignant disease within one year 11) Unable to receive contrast enhanced CT nor MRI due to allergic reaction to contrast medium 12) Pregnant females, possibly pregnant females, females wishing to become pregnant, and males that are currently attempting to produce a pregnancy 13) Inadequate physical condition, as diagnosed by primary physician
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Middle name Last name Tomoo Kosuge
Organization	National Cancer Center Hospital
Division name	Hepato-Biliary-Pancreatic Surgery Division
Zip code
Address	5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL	03-3542-2511
Email	tkosuge@ncc.go.jp

Public contact
Name of contact person	1st name Middle name Last name Hideki Ueno
Organization	National Cancer Center Hospital
Division name	Hepatobiliary and Pancreatic Oncology Divison
Zip code
Address	5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL	03-3542-2511
Homepage URL	http://mhlw-grants.niph.go.jp/
Email	hiueno@ncc.go.jp

Sponsor
Institute	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
Address
Tel
Email

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	2010 Year 10 Month 20 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	No longer recruiting
Date of protocol fixation	2010 Year 10 Month 19 Day
Date of IRB
Anticipated trial start date	2010 Year 11 Month 01 Day
Last follow-up date	2015 Year 11 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2010 Year 10 Month 19 Day
Last modified on	2016 Year 04 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005242

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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