UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011806 |
|---|---|
| Receipt number | R000013805 |
| Scientific Title | Randomized phase II study of Gemcitabine and S-1 combination therapy versus S-1 in patients with Gemcitabine-refractory unresectable advanced Pancreatic Cancer |
| Date of disclosure of the study information | 2013/09/19 |
| Last modified on | 2019/03/29 10:30:20 |
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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 unresectable advanced Pancreatic Cancer
Acronym
Randomized phase II study of GS vs. S-1 in patients with Gem-refractory unresectable advanced Pancreatic Cancer
Scientific Title
Randomized phase II study of Gemcitabine and S-1 combination therapy versus S-1 in patients with Gemcitabine-refractory unresectable advanced Pancreatic Cancer
Scientific Title:Acronym
Randomized phase II study of GS vs. S-1 in patients with Gem-refractory unresectable advanced Pancreatic Cancer
Region
| Japan |
Condition
Condition
unresectable 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 GS and S-1 as a second-line treatment for Gem-refractory unresectable 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
Overall survival, Disease Control Rate, Response Rate, Relative Dose Intensity, Adverse Events, Time to Treatment failure
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
Control arm:S-1 q6w
Patients receive S-1 alone (80-120mg/day, day1-28) every 6 weeks. It is repeated until obvious evidence of Disease Progression, patient refusal, or unacceptable toxicity.
Interventions/Control_2
Testing arm:Gem+S-1 q4w
Patients receive S-1(80-120mg/day, day1-21) plus Gemcitabine(800mg/m2, day1,15) every 4 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)Unresectable pancreatic cancer(without Recurrent cancer)
2)Age 20-
3)PS(ECOG) 0-1
4)Refractory Gem monotherapy or Gem combination therapy
5)Over 2 weeks after previous Gem chemotherapy
6)Sufficient oral intake
7)Metastatic pancreatic adenocarcinoma with measurable lesion according to RECSTver 1.1
8)Biliary drainage was applied adequately in patients with obstructive jaundice
9)Adequate organ functions
10)Written informed consent
Key exclusion criteria
1)Patients who have previously administered 5-FU including S-1
2)Severe complications
3)Simultaneous or metachronous (within 5 years) double cancers, with the exception of intramucosal tumor curable with local therapy
4)Severe Gem hypersensitivity
5)Patients who have not undergone radiotherapy
6)Active infections
7)Patients with HBs antigen-positive or with HCV antibody-positive
8)Patients who have previous history of radiotherapy to the chest
9)Uncontrollable watery diarrhea
10)Presence of metastasis in central nervous system
11)Severe mental disorders
12)Pregnant or lactating women, or women with known or suspected pregnancy and men who want let to pregnancy
13)Required to continue to take flucytosine, phenytoin, and warfarin
14)Patients seems inadequate for this study by investigators
Target sample size
116
Research contact person
Name of lead principal investigator
| 1st name | Tetsuo |
| Middle name | |
| Last name | Takehara |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
565-0871
Address
2-2 Yamadaoka, Suita, Osaka 565-0871 Japan
TEL
06-6879-3621
takehara@gh.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Minoru |
| Middle name | |
| Last name | Shigekawa |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
5650871
Address
2-2 Yamadaoka, Suita, Osaka 565-0871 Japan
TEL
06-6879-3621
Homepage URL
m-shigekawa@gh.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka Pancreas Forum
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
Osaka University
Address
2-2 Yamadaoka, Suita, Osaka 565-0871 Japan
Tel
06-6879-3621
m-shigekawa@gh.med.osaka-u.ac.jp
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
| 2013 | Year | 09 | Month | 19 | 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
49
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
Main results already published
Date of protocol fixation
| 2013 | Year | 09 | Month | 19 | Day |
Date of IRB
| 2013 | Year | 09 | Month | 19 | Day |
Anticipated trial start date
| 2013 | Year | 09 | Month | 20 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 09 | Month | 19 | Day |
Last modified on
| 2019 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013805
