UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014339 |
|---|---|
| Receipt number | R000016694 |
| Scientific Title | Phase I/II study of S-1, irinotecan plus oxaliplatin combination therapy (SOXIRI) for advanced pancreatic cancer(KANAPS 06 study) |
| Date of disclosure of the study information | 2014/06/22 |
| Last modified on | 2014/06/22 21:53:55 |
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Basic information
Public title
Phase I/II study of S-1, irinotecan plus oxaliplatin combination therapy (SOXIRI) for advanced pancreatic cancer(KANAPS 06 study)
Acronym
Phase I/II study of SOXIRI for advanced pancreatic cancer(KANAPS 06 study)
Scientific Title
Phase I/II study of S-1, irinotecan plus oxaliplatin combination therapy (SOXIRI) for advanced pancreatic cancer(KANAPS 06 study)
Scientific Title:Acronym
Phase I/II study of SOXIRI for advanced pancreatic cancer(KANAPS 06 study)
Region
| Japan |
Condition
Condition
advanced pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to determine the recommended dose for the phase II study and to evaluate the response rate in the phase II study.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
phase I study: Safety,Frequency of DLTs
phase II study: response rate
Key secondary outcomes
progression-free survival, overall survival, and adverse events
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
L-OHP: fixed dose
IRI: dose escalation
S-1: fixed dose
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Pathologically diagnosed invasive ductal carcinoma
2) Unresectable locally advanced, metastatic, or recurrent disease
3) No prior chemotherapy or radiotherapy for pancreatic cancer
4) Aged 20 to 75 years old
5) ECOG PS of 0 or 1
6) Adequate organ functions
7) Sufficient oral intake
8) Written informed consent
Key exclusion criteria
1) Grade 2 or greater peripheral neuropathy
2) Having UGT1A1*6/*6, UGT1A1*28/*28, or UGT1A1*6/*28 gene
3) Moderate ascites
4)Intestinal pneumonitis or pulmonary fibrosis
5) Uncontrollable diarrhea
6) Serious complications (organ failure, uncontrolled diabetes mellitus, active infection, ulcer, ileus, mental disorders, or central nervous system disorders)
7) Active double cancer
8) Pregnancy
9)Inappropriate for this study judged by the attending physician
Target sample size
53
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroaki Yanagimoto |
Organization
Kansai Medical University
Division name
Surgery Division
Zip code
Address
2-5-1,Shinmachi,Hirakata,Osaka 573-1191, Japan
TEL
072-804-0101
yanagimh@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomohisa Yamamoto |
Organization
Kansai Medical University
Division name
Surgery Division
Zip code
Address
2-5-1,Shinmachi,Hirakata,Osaka 573-1191, Japan
TEL
072-804-0101
Homepage URL
tomot1226@yahoo.co.jp
Sponsor or person
Institute
KANAPS(Kansai and Nara Pancreatobiliary Study group)
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
| 2014 | Year | 06 | Month | 22 | 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
| 2014 | Year | 03 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 03 | Month | 31 | 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
| 2014 | Year | 06 | Month | 22 | Day |
Last modified on
| 2014 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016694
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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