UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017002
Receipt number 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 2022/09/18 17:18:46

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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 or person

Institute

Hokkaido University Hospital Cancer Center

Institute

Department

Personal name



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

Published


Result

URL related to results and publications

https://doi.org/10.1002/onco.13838

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

2021 Year 06 Month 21 Day

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

2022 Year 09 Month 18 Day



Link to view the page

Value
https://center6.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