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Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000002000
Receipt No. R000002431
Scientific Title A randomized phase II trial of adjuvant Chemotherapy with Gemcitabine alone, S-1 alone, versus gemcitabine and S-1 in patients with resected pancreatic cancer
Date of disclosure of the study information 2009/05/25
Last modified on 2014/11/04

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Basic information
Public title A randomized phase II trial of adjuvant Chemotherapy with Gemcitabine alone, S-1 alone, versus gemcitabine and S-1 in patients with resected pancreatic cancer
Acronym CAP-002
Scientific Title A randomized phase II trial of adjuvant Chemotherapy with Gemcitabine alone, S-1 alone, versus gemcitabine and S-1 in patients with resected pancreatic cancer
Scientific Title:Acronym CAP-002
Region
Japan

Condition
Condition Incasive ductal carcinoma of pancreas with macroscopic complete resection
Classification by specialty
Surgery in general Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To estimate the efficacy and feasibility of gemcitabine alone, S-1 alone, and gemcitabine and S-1 combination therapy as adjuvant chemotherapy for resected pancreatic cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Two year disease-free survival rate
Key secondary outcomes overall survival, toxicity, completion rate

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 NO
Institution consideration Institution is considered as a block.
Blocking NO
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Gemcitabine adjuvant chemotherapy:
Three weekly infusions of gemcitabine at 1000mg/m2 followed by 1week pause as 1 course.
total 12 courses
Interventions/Control_2 S-1 adjuvant chemotherapy:
S-1 80mg/m2/day for 14days followed by 1week pause as 1 course.
total 16 courses
Interventions/Control_3 Gemcitabine and S-1 combination adjuvant chemotherapy:
S-1 60mg/m2/day for 14days and gemcitabine 1000mg/m2 at day8 and 15 within 21days as 1 course.
total 16 courses
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1. Patients who had pancratic cancer histologically verified as invasive ductal carcinoma and who had undergone macroscopic complete resection.
2. Being aged 20 years or older and 79 years or younger at the time of registration.
3. Without prior radiation or chemotherapy.
4. With performans status 0-2 level.
5. Adequate hematologic, renal and hepatologic function
WBC => 4000/mm3
neutrophil => 2000/mm3
Platelet => 100000/mm3
Hemoglobin => 9.0 g/dl
AST, ALT <= ULN X 2.5
Total bilirubin < 3.0 mg/dl
Creatinine <= ULN
6. Provided written informed consent.
Key exclusion criteria 1. Inadequate physical condition for gemcitabine or S-1 treatmetn according to manufacture's instruction
2. With pulmonary fibrosis or interstitial pneumonia
3. Massive pleural effusion
4. With distant metastasis
5. Active malignancies other than pancreatic cancer
6. Active infectious disease
7. Severe post operative complications
8. Severe angina, cardiac infurction within 3 months at the registration, and severe hear failure
9. Severe diabetes or hypertension
10. Severe mental disorder
11. Pregnancy, breast feeding, or women who desire to preserve fecundity
12. Inadequate physical condition, as diagnosed by primary physician
Target sample size 96

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaru Miyazaki
Organization Chiba unviersity, Graduate School of Medicine
Division name General Surgery
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba, 260-8677, JAPAN
TEL 043-222-7171(ext.5283)
Email masaru@faculty.chiba-u.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hideyuki Yoshitomi
Organization Chiba unviersity, Graduate School of Medicine
Division name General Surgery
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba, 260-8677, JAPAN
TEL 043-222-7171(ext.5283)
Homepage URL
Email yoshitomi@faculty.chiba-u.jp

Sponsor
Institute Chiba study group of adjuvant chemotherapy for pancreatic cancer
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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
2009 Year 05 Month 25 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
2006 Year 12 Month 22 Day
Date of IRB
Anticipated trial start date
2007 Year 01 Month 01 Day
Last follow-up date
2012 Year 11 Month 30 Day
Date of closure to data entry
2012 Year 12 Month 31 Day
Date trial data considered complete
2013 Year 01 Month 15 Day
Date analysis concluded
2013 Year 04 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 05 Month 23 Day
Last modified on
2014 Year 11 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002431

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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