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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000014339
Receipt No. 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

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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
Email 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
Email tomot1226@yahoo.co.jp

Sponsor
Institute KANAPS(Kansai and Nara Pancreatobiliary Study group)
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016694

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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