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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000022964
Receipt No. R000026475
Scientific Title A phase I study of the combination chemotherapy of IRISOX (irinotecan/S-1/oxaliplatin) in gemcitabine-refractory pancreatic cancer
Date of disclosure of the study information 2016/07/01
Last modified on 2018/03/07

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Basic information
Public title A phase I study of the combination chemotherapy of IRISOX (irinotecan/S-1/oxaliplatin) in gemcitabine-refractory pancreatic cancer
Acronym IRISOX for gemcitabine-refractory pancreatic cancer
Scientific Title A phase I study of the combination chemotherapy of IRISOX (irinotecan/S-1/oxaliplatin) in gemcitabine-refractory pancreatic cancer
Scientific Title:Acronym IRISOX for gemcitabine-refractory pancreatic cancer
Region
Japan

Condition
Condition gemcitabine-refractory 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 determine the recommended dose for the phase I study.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes Phase I: MTD, RD
Key secondary outcomes Safety, Response rate, Progression free survival, Overall survival

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 CPT-11: dose escalation
S-1: fixed dose
L-OHP: 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 proven Adenocarcinoma or Adenosquamous carcinoma
2.resistant /intolerable to gemcitabine
3.with a rest longer than 14 days after the end of prior therapy
4.Age 20-75
5.ECOG PS of 0-1
6.expected survival period longer than 2 months
7.Sufficient oral intake
8.The subject has measurable disease.
9.Adequate organ functions
10.Written informed consent
Key exclusion criteria 1.Patients with contraindication for the medication of Irinotecan, S-1 and L-OHP
2.History of serious drug hypersensitivity or a history of drug allergy
3.Pregnancy
4.Active infection
5.Severe complications (Grade 3,4 CTCAE v4.0)
6.Peripheral neuropathy(Grade 2,3,4 CTCAE v4.0)
7.Serious diarrhea(Grade 2,3,4 CTCAE v4.0)
8.Intestinal pneumonitis or pulmonary fibrosis
9.Much ascites or pleural effusion or pericardial effusion
10.Active double cancer
11.Symptomatic brain metastasis
12.Regular use of frucitocin, fenitoin or warfarin
13.Having UGT1A1*6/*6, UGT1A1*28/*28, or UGT1A1*6/*28 gene
14.Active Hepatitis B
15.Inappropriate for this study judged by the attending physician
Target sample size 18

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsuhiro Kida
Organization Kitasato University School of Medicine
Division name Department of Gastroenterology
Zip code
Address 1-15-1 Kitasato Minami Sagamihara Kanagawa 252-0374 Japan
TEL +81-42-778-8111
Email m-kida@kitasato-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kosuke Okuwaki
Organization Kitasato University School of Medicine
Division name Department of Gastroenterology
Zip code
Address 1-15-1 Kitasato Minami Sagamihara Kanagawa 252-0374 Japan
TEL +81-42-778-8111
Homepage URL
Email kokuwaki@kitasato-u.ac.jp

Sponsor
Institute Kitasato University School of Medicine
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
2016 Year 07 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 No longer recruiting
Date of protocol fixation
2016 Year 06 Month 28 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 01 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
2016 Year 07 Month 01 Day
Last modified on
2018 Year 03 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026475

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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