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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000004410
Receipt No. R000005242
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)
Date of disclosure of the study information 2010/10/20
Last modified on 2016/04/19

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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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