UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007173 |
|---|---|
| Receipt number | R000008441 |
| Scientific Title | Randomized phase II study of gemcitabine and S-1 combination therapy versus S-1 in patients with gemcitabine-refractory advanced pancreatic cancer |
| Date of disclosure of the study information | 2012/02/01 |
| Last modified on | 2012/01/31 05:00:34 |
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Basic information
Public title
Randomized phase II study of gemcitabine and S-1 combination therapy versus S-1 in patients with gemcitabine-refractory advanced pancreatic cancer
Acronym
Randomized phase II study of gemcitabine and S-1 combination therapy versus S-1 in patients with gemcitabine-refractory advanced pancreatic cancer
Scientific Title
Randomized phase II study of gemcitabine and S-1 combination therapy versus S-1 in patients with gemcitabine-refractory advanced pancreatic cancer
Scientific Title:Acronym
Randomized phase II study of gemcitabine and S-1 combination therapy versus S-1 in patients with gemcitabine-refractory advanced pancreatic cancer
Region
| Japan |
Condition
Condition
advanced 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 safety and efficacy of a gemicitabin plus S-1and S-1 alone as a second-line treatment for gemcitabine-refractory advanced pancreatic cancer patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
progression-free survival
Key secondary outcomes
response rate, overall survival, adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Uncontrolled
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
A: Patients receive gemcitabine(1,000 mg/m2, day1,8) plus S-1(60-100 mg/day, day1-14) every 3 weeks. It is repeated until obvious evidence of disease progression, patient refusal, or unacceptable toxicity.
Interventions/Control_2
B: Patients receive S-1 alone (80-120 mg/day, day1-28 every 6 weeks). It is repeated until obvious evidence of disease progression, patient refusal, or unacceptable toxicity.
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
1)Diagnosed as pancreatic cancer
2)Recurrent or unresectable pancreatic cancer
3)Histologically proven invasive ductal pancreatic cancer
4)Refractory to gemcitabine monotherapy or gemcitabine combination therapy exclusive 5-FU chemotherapy (recurrent within 6 months after gemcitabine adjuvant therapy is eligible)
5)Gemcitabine chemotherapy over 4weeks
6)ECOG PS of 0,1 or 2
7)Sufficient oral intake
8)Aged over 20 years old
9)Adequate organ functions
10)Written informed consent
Key exclusion criteria
1)With moderate or more pleural effusion/ ascites
2)Interstitial pneumonia or fibroid lung
3)Cardiac insufficiency or myocardial infarction within six months
4)Active bacterial or fungous infection
5)Uncontrollable diabetes mellitus
6)Psychosis or severe mental disorder
7)Severe drug allergy
8)Simultaneous or metachronous (within 3 years) double cancers, with the exception of intramucosal tumor curable with local therapy
9) Previous chemotherapy or radiotherapy against any other malignancies within 3 years
10)Over 6 months after adjuvant gemcitabine chemotherapy
11)With CNS metastas
12)Patients requiring the administration of flucytosine, phenytoin or warfarin potassium
13)Pregnant, lactating women or women of childbearing potential
14)Men who want to get partner pregnant
15)Inadequate physical condition, as diagnosed by primary physician
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuya Mine |
Organization
Tokai University Hospital
Division name
Division of medical gastroenterology
Zip code
Address
143 Shimokasuya Isehara city
TEL
0463-93-1121
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Ueno |
Organization
Kanagawa Cancer Center
Division name
Division of hepatobiliary and pancreatic medical oncology
Zip code
Address
1-1-2 Nakao Asahi-ku Yokohama City
TEL
045-391-5761
Homepage URL
kantansui@kcch.jp
Sponsor or person
Institute
Tokai University Hospital
Kanagawa 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
| 2012 | Year | 02 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 09 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 02 | 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
| 2012 | Year | 01 | Month | 31 | Day |
Last modified on
| 2012 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008441
