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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017002
Receipt No. R000019724
Scientific Title Phase 1 trial of Oxaliplatin/IRInotecan/S-1 (OX-IRIS) as first line chemotherapy for unresectable pancreatic cancer
Date of disclosure of the study information 2015/04/01
Last modified on 2019/10/06

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Basic information
Public title Phase 1 trial of Oxaliplatin/IRInotecan/S-1 (OX-IRIS) as first line chemotherapy for unresectable pancreatic cancer
Acronym HGCSG1403
Scientific Title Phase 1 trial of Oxaliplatin/IRInotecan/S-1 (OX-IRIS) as first line chemotherapy for unresectable pancreatic cancer
Scientific Title:Acronym HGCSG1403
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 based on the observed dose-limiting toxicities.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes frequency of DLT (Dose Limiting Toxicity) , determination of MTD (Maximum Tolerated Dose)
Key secondary outcomes the frequency of side effect, 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 oxaliplatin, irinotecan, S-1
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)
8) Active double cancer
9) Pregnancy
10)Inappropriate for this study judged by the attending physician
Target sample size 18

Research contact person
Name of lead principal investigator
1st name Yoshito
Middle name
Last name Komatsu
Organization Hokkaido University Hospital
Division name Cancer Center
Zip code 060-8638
Address North 15, West 7, Kita-ku, Sapporo, 060-8638, Japan
TEL 011-716-1161
Email ykomatsu@med.hokudai.ac.jp

Public contact
Name of contact person
1st name Yasuyuki
Middle name
Last name Kawamoto
Organization Hokkaido University Hospital
Division name Gastroenterology and Hepatology
Zip code 060-8638
Address North 15, West 7, Kita-ku, Sapporo,
TEL 011-716-1161
Homepage URL
Email y-kawamoto0716@hotmail.co.jp

Sponsor
Institute Hokkaido University Hospital Cancer Center
Institute
Department

Funding Source
Organization Hokkaido Gastrointestinal Caner Study Group (HGCSG)
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Institutional Review Board of Hokkaido University Hospital
Address Kita 14 Nishi 5, Kita-ku, Sapporo
Tel 011-706-7636
Email crjimu@huhp.hokudai.ac.jp

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
2015 Year 04 Month 01 Day

Related information
URL releasing protocol Not applicable
Publication of results Partially published

Result
URL related to results and publications Not applicable
Number of participants that the trial has enrolled 13
Results
Two of five enrolled in level 0 (L-OHP: 85 mg/m2, IRI: 100 mg/m2, S-1: 80 mg/m2) had DLT. One of six in level -1 (L-OHP: 65 mg/m2, IRI: 100 mg/m2, S-1: 80 mg/m2) had DLT. 
At level 0, 100% of cases had anemia and fatigue, 80% anorexia, diarrhea, peripheral sensory neuropathy, 60% platelet count decrease. 
At level -1, 100% had anemia, 75% nausea and fatigue, 63% anorexia. 
Results date posted
2019 Year 10 Month 06 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The patients' backgrounds were median age 62; male /female, 9/4; the primary tumor sites head /body and tail, 8/5; ECOG PS 0/1, 7/6; UR-LA /UR-M, 4/9. 
Participant flow
Two of five enrolled in level 0 (L-OHP: 85 mg/m2, IRI: 100 mg/m2, S-1: 80 mg/m2) had DLT. One of six in level -1 (L-OHP: 65 mg/m2, IRI: 100 mg/m2, S-1: 80 mg/m2) had DLT. 
Adverse events
At level 0, 100% of cases had anemia and fatigue, 80% anorexia, diarrhea, peripheral sensory neuropathy, 60% platelet count decrease. 
At level -1, 100% had anemia, 75% nausea and fatigue, 63% anorexia. 
Outcome measures
Response rate was 10% and disease control rate was 70% in ten cases with evaluable lesion. Median PFS was 4.1 months (95%C.I.; 0.0-8.6 months). Median OS was 13.7 months (95%C.I.; 5.9-21.5 months).
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2015 Year 10 Month 26 Day
Date of IRB
2015 Year 10 Month 23 Day
Anticipated trial start date
2015 Year 11 Month 02 Day
Last follow-up date
2018 Year 08 Month 25 Day
Date of closure to data entry
2018 Year 09 Month 30 Day
Date trial data considered complete
2018 Year 10 Month 31 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 04 Month 01 Day
Last modified on
2019 Year 10 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019724

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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