UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011756 |
|---|---|
| Receipt number | R000010996 |
| Scientific Title | Randomized study of fentanyl citrate versus Oxycodone Hydrochloride Hydrate in patients with unresectable advanced pancreatic cancer |
| Date of disclosure of the study information | 2013/09/13 |
| Last modified on | 2013/09/13 18:20:17 |
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Basic information
Public title
Randomized study of fentanyl citrate versus Oxycodone Hydrochloride Hydrate in patients with unresectable advanced pancreatic cancer
Acronym
FRONTIER
Scientific Title
Randomized study of fentanyl citrate versus Oxycodone Hydrochloride Hydrate in patients with unresectable advanced pancreatic cancer
Scientific Title:Acronym
FRONTIER
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
To assess the improvement ofgastrointestinal disorders and quality of life,safety,efficacy of Transdermal fentanyl citrate compared with oxycodone hydrochloride hydrate in randomized study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
The rates of gastrointestinal disorders events in four weeks
Key secondary outcomes
quality of life,the rates of opioid rotation,pain score,the period until stable pain control ,overall survival time, The rates of adverse event
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Arm A:Oxycodone hydrochloride hydrate 10mg every 12 hours
Arm B: Transdermal fentanyl citrate 1mg once a day
Interventions/Control_2
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
unresectable advanced pancreatic cancer
The case judged that 15-25mg oxycodone hydrochloride hydrate or more per day is required to cancer pain
Key exclusion criteria
serious liver, kidney, cardiac disorders, pulmonary impairment, and nervous system and psychic disorders
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Minori Odanaka |
Organization
National Cancer Center Hospital
Division name
Clinical Trial Support Office
Zip code
Address
Tsukiji 5-1-1, Chuo-ku, Tokyo 104-0045, Japan
TEL
03-3547-5201
minochant23@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Minori Odanaka |
Organization
National Cancer Center Hospital
Division name
Clinical Trial Support Office
Zip code
Address
Tsukiji 5-1-1, Chuo-ku, Tokyo 104-0045, Japan
TEL
03-3547-5201
Homepage URL
modanaka@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
Welfare labor science research cost
Organization
Division
Category of Funding Organization
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
| 2013 | Year | 09 | Month | 13 | 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
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 03 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | Month | 27 | Day |
Last follow-up date
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 | 13 | Day |
Last modified on
| 2013 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010996
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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