UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002244 |
|---|---|
| Receipt number | R000002599 |
| Scientific Title | A phase 3 study of gemcitabine and S-1 compared with gemcitabine monotherapy in patients with unresectable advanced pancreatic cancer. |
| Date of disclosure of the study information | 2009/07/24 |
| Last modified on | 2016/04/12 19:52:28 |
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Basic information
Public title
A phase 3 study of gemcitabine and S-1 compared with gemcitabine monotherapy in patients with unresectable advanced pancreatic cancer.
Acronym
A phase 3 study of GEM and S-1 compared with GEM for unresectable advanced pancreatic cancer.
Scientific Title
A phase 3 study of gemcitabine and S-1 compared with gemcitabine monotherapy in patients with unresectable advanced pancreatic cancer.
Scientific Title:Acronym
A phase 3 study of GEM and S-1 compared with GEM for unresectable advanced pancreatic cancer.
Region
| Japan |
Condition
Condition
pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the efficacy of gemcitabine and S-1 compared with gemcitabine monotherapy in patients with unresectable advanced pancreatic cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
progression free survival
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
S-1 60mg/m2/day is administered orally twice daily from the evening of day 1 to the morning of day 15 followed by a one week rest. Gemcitabine 1000mg/m2 was administered in a 30-min intravenous infusion on days 8 and 15 of each cycle. The cycle was repeated every 21 days until disease progression.
Interventions/Control_2
Gemcitabine 1000mg/m2 was administered in a 30min intravenous infusion on day 1, 8, 15. The cycle was repeated every 4 weeks until disease progression.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1)Histopathologically proven advanced pancreatic cancer
(2)20 - 79 years of age,
(3)ECOG PS 0 or 1
(4)No prior chemotherapy or radiotherapy
(5)Oral intake is possible
(6)Written informed consent
(7)Adequate organ function
Key exclusion criteria
(1)severe concurrent disease,
(2)interstitial pneumonia,
(3)massive abdominal or pleural effision
(4)mental disoeder,
(5)active concomitant malignancy,
(6)severe diarrhea,
(7)brain metastasis,
(8)severe drug hypersensitibity,
(9)pregnant or lactating females,
(10)regular use of phenytoin, warfarin or frucitocin,
(11)inappropriate for entry onto the study, as diagnosed by primary physician.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Taketo Yamaguchi |
Organization
Chiba Cancer Center
Division name
Gastroenterology
Zip code
Address
666-2, Nitona-cho, Chuo-ku, Chiba
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kentaro Sudo |
Organization
Chiba Cancer Center
Division name
Gastroenterology
Zip code
Address
TEL
Homepage URL
kesudou-gi@umin.ac.jp
Sponsor or person
Institute
Chiba Cancer Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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 | 07 | Month | 24 | 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 | 10 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2012 | 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
| 2009 | Year | 07 | Month | 23 | Day |
Last modified on
| 2016 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002599
