UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004410 |
|---|---|
| Receipt number | 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 09:21:11 |
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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
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/
hiueno@ncc.go.jp
Sponsor or person
Institute
Japanese Study Group of Adjuvant Therapy for Pancreatic Cancer (JSAP)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005242
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