UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000655 |
|---|---|
| Receipt number | 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 16:01:55 |
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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
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
k.uesaka@scchr.jp
Sponsor or person
Institute
Japan Adjuvant Study Group of Pancreatic Cancer (JASPAC)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000791
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