UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012054
Receipt number R000014073
Scientific Title Phase I study of S-1, irinotecan plus oxaliplatin combination therapy (S-IROX) for advanced pancreatic cancer
Date of disclosure of the study information 2013/10/16
Last modified on 2013/10/15 19:49:01

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Basic information

Public title

Phase I study of S-1, irinotecan plus oxaliplatin combination therapy (S-IROX) for advanced pancreatic cancer

Acronym

Phase I study of S-IROX for advanced pancreatic cancer

Scientific Title

Phase I study of S-1, irinotecan plus oxaliplatin combination therapy (S-IROX) for advanced pancreatic cancer

Scientific Title:Acronym

Phase I study of S-IROX for advanced pancreatic cancer

Region

Japan


Condition

Condition

pancreatic cancer

Classification by specialty

Hepato-biliary-pancreatic medicine Hematology and clinical oncology Adult

Classification by malignancy

Malignancy

Genomic information

YES


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

Safety
Frequency of DLTs

Key secondary outcomes

response rate, 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: dose escalation

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

24


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hideki Ueno

Organization

National Cancer Center Hospital

Division name

Hepatobiliary and Pancreatic Oncology Division

Zip code


Address

5-1-1, Tsukiji, Chuo-ku, Tokyo 104-0045, Japan

TEL

03-3542-2511

Email

hiueno@ncc.go.jp


Public contact

Name of contact person

1st name
Middle name
Last name Satoshi Shiba

Organization

National Cancer Center Hospital

Division name

Hepatobiliary and Pancreatic Oncology Division

Zip code


Address

5-1-1, Tsukiji, Chuo-ku, Tokyo 104-0045, Japan

TEL

03-3542-2511

Homepage URL


Email

sashiba@ncc.go.jp


Sponsor or person

Institute

National Cancer Center Hospital

Institute

Department

Personal name



Funding Source

Organization

Ministry of Health, Labor and Welfare

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan


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

国立がん研究センター中央病院


Other administrative information

Date of disclosure of the study information

2013 Year 10 Month 16 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

2013 Year 09 Month 12 Day

Date of IRB


Anticipated trial start date

2013 Year 10 Month 15 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

2013 Year 10 Month 16 Day

Last modified on

2013 Year 10 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014073


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name