UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002000 |
|---|---|
| Receipt number | 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 22:45:41 |
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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)
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
yoshitomi@faculty.chiba-u.jp
Sponsor or person
Institute
Chiba study group of adjuvant chemotherapy for pancreatic cancer
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002431
