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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000655
Receipt No. R000000791
Scientific Title Randomiszd phase III trial of adjuvant chemotherapy with gemcitabine vs. S-1 in patients with resected pancreatic cancer
Date of disclosure of the study information 2007/04/01
Last modified on 2019/02/22

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Basic information
Public title Randomiszd phase III trial of adjuvant chemotherapy with gemcitabine vs. S-1 in patients with resected pancreatic cancer
Acronym Randomized phase III trial of adjuvant chemotherapy with gemcitabine vs. S-1 for pancreatic cancer (JASPAC 01)
Scientific Title Randomiszd phase III trial of adjuvant chemotherapy with gemcitabine vs. S-1 in patients with resected pancreatic cancer
Scientific Title:Acronym Randomized phase III trial of adjuvant chemotherapy with gemcitabine vs. S-1 for pancreatic cancer (JASPAC 01)
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 non-inferiority in survival following adjuvant chemoterpy with S-1 against gemcitabine in patients with resected pancreatic cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes Overall survival
Key secondary outcomes Incidence of adverse events
Relapse-free survival
Health-related quality of life

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 NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Gemcitabine 1000 mg/m2 is given by intravenous infusion over 30 minutes on days 1, 8, and 15, followed by a 1-week pause. This cycle is repeated for six months or until recurrent disease is confirmed.
Interventions/Control_2 S-1 40mg/m2 is given orally twice a day for four weeks, followed by a two-week rest. This course is repeated four times or until recurrent disease 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

Not applicable
Gender Male and Female
Key inclusion criteria Eligible criteria are as follows:
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:
leukocytes >= 3,000 /mm3 and <= 12,000 /mm3, platelets >= 100,000 /mm3, hemoglobin >= 8.0 g/dL, serum total bilirubin <= 2.0 mg/dL, serum aspartate aminotransferase (AST) <= 100 IU/L, serum alanine aminotransferase (ALT) <= 100 IU/L, and serum creatinine <= 1.2 mg/dL
10) Written informed consent
Key exclusion criteria Exclusion criteria are as folllows:
1) Prior history of gemcitabine therapy or S-1 therapy
2) Recurrent disease on enrollment
3) Massive ascites or pleural effusion
4) Plumonary fibrosis or interstitial pneumonia
5) Severe diarrhea
6) NYHA III or IV cardiac function
7) Myocardial infarction within six months
8) Severe infection
9) Severe diabetes
10) Blood transfusion within two weeks
11) Other severe complications such as heart failure, renal failure, liver failure, peptic ulcer, intestinal paralysis, etc
12) Severe mental disorder
13) Severe drug allergy
14) Other active malignancy
15) Pregnancy, breast feeding, or women who desire to preserve fecundity
16) Men who desire to have children
17) Regular use of frucitocin, fenitoin or warfarin
18) Inadequate physical condition, as diagnosed by primary physician
Target sample size 360

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Katsuhiko Uesaka
Organization Shizuoka Cancer Center Hospital
Division name Division of Hepato-Biliary-Pancreatic Surgery
Zip code
Address 1007, Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777 JAPAN
TEL 055-989-5222
Email k.uesaka@scchr.jp

Public contact
Name of contact person
1st name
Middle name
Last name Katsuhiko Uesaka
Organization Shizuoka Cancer Center Hospital
Division name Division of Hepato-Biliary-Pancreatic Surgery
Zip code
Address 1007, Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777 JAPAN
TEL 055-989-5222
Homepage URL
Email k.uesaka@scchr.jp

Sponsor
Institute Japan Adjuvant Study Group of Pancreatic Cancer (JASPAC)
Institute
Department

Funding Source
Organization Pharma Valley Center, Shizuoka Organization for Creation Industries
Organization
Division
Category of Funding Organization Non profit foundation
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
2007 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2007 Year 02 Month 16 Day
Date of IRB
Anticipated trial start date
2007 Year 04 Month 01 Day
Last follow-up date
2015 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2007 Year 03 Month 27 Day
Last modified on
2019 Year 02 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000791

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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