UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016945 |
|---|---|
| Receipt number | R000019651 |
| Scientific Title | A phase I/II study of chemotherapy using Irinotecan, S-1 plus Oxaliplatin (IRISOX therapy) for unresectable pancreatic cancer |
| Date of disclosure of the study information | 2015/03/27 |
| Last modified on | 2018/01/23 17:51:57 |
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Basic information
Public title
A phase I/II study of chemotherapy using Irinotecan, S-1 plus Oxaliplatin (IRISOX therapy) for unresectable pancreatic cancer
Acronym
IRISOX therapy for unresectable pancreatic cancer
Scientific Title
A phase I/II study of chemotherapy using Irinotecan, S-1 plus Oxaliplatin (IRISOX therapy) for unresectable pancreatic cancer
Scientific Title:Acronym
IRISOX therapy for unresectable pancreatic cancer
Region
| Japan |
Condition
Condition
unresectable 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 II study and to evaluate the response rate in the phase II study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
Phase I : MTD, RD
Phase II : response rate
Key secondary outcomes
Safety, progression-free 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
Irinotecan: dose escalation
S-1: dose escalation
Oxaliplatin: 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 Adenocarcinoma or Adenosquamous carcinoma
2. Aged 20 to 75 years old
3. ECOG PS of 0 or 1
4. Life expectancy > 3 months.
5. Sufficient oral intake
6. Unresectable
7. The subject has measurable disease.
8. No prior therapy for pancreatic cancer
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
6. Peripheral neuropathy
7. Serious diarrhea
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. HBV carrier who has to take nucleotide analogues during chemotherapy
15. Inappropriate for this study judged by the attending physician
Target sample size
25
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
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
kokuwaki@kitasato-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology
Kitasato University School of Medicine
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
北里大学病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 03 | Month | 27 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 03 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | 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
| 2015 | Year | 03 | Month | 27 | Day |
Last modified on
| 2018 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019651
