UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012975
Receipt number R000015149
Scientific Title A I/II phase study of chemotherapy using irinotecan plus L-OHP plus S-1 treatment (SOXIRI) for unresectable advanced pancreatic cancer
Date of disclosure of the study information 2014/01/27
Last modified on 2014/01/27 16:04:36

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Basic information

Public title

A I/II phase study of chemotherapy using irinotecan plus L-OHP plus S-1 treatment (SOXIRI) for unresectable advanced pancreatic cancer

Acronym

A phase I/II study of chemotherapy(SOXIRI)

Scientific Title

A I/II phase study of chemotherapy using irinotecan plus L-OHP plus S-1 treatment (SOXIRI) for unresectable advanced pancreatic cancer

Scientific Title:Acronym

A phase I/II study of chemotherapy(SOXIRI)

Region

Japan


Condition

Condition

unresectable advanced pancreatic cancer

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Exploring for SOXIRI of MTD and DLT and RD.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

MTD and DLT and RD

Key secondary outcomes



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 is administered with 90 min intravenous infusion on day 1,15 every 4 weeks.
L-OHP is administered with 120 min intravenous infusion on day 1,15 every 4 weeks.
S-1 is taken orally on day 1-14 every 4 weeks.20

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

80 years-old >

Gender

Male and Female

Key inclusion criteria

(1)unresectable invasive or reccurence advanced pancraatic carcinoma
(2)first line treatment
(3)Patients must be >=20 years old and <=80 years old
(4)ECOG Performance Status must be 0 or 1.
(5)The following criteria must be satisfied in laboratory tests.
1) Hemoglobin >= 9.0 g/dL
2) White blood cell count >=3,000/mm3
,Neutrophil count >=1,500/mm3
3)Platelet count >=75,000mm3
4)Total bilirubin <=one and a half times as many as average level baseline
5)AST,ALT,ALP<= two and a half times as many as average level baseline
6) Serum Creatinine <=average level baseline
(6)Life expectancy > 90 days.
(7)Patients or legal representative must have signed the consent form.

Key exclusion criteria

(1) infusion of blood products within 7days
(2) not first line treatment
(3) severe Allergie
(4) much ascites or pleural effusion
(5) infection
(6) diarrea
(7) ileus
(8) neuropathy
(9) severe heart disorder
(10) neuropsychiatric disorder
(11) idiopathic pulmonary fibrosis or Idiopathic interstitial pneumonia
(12) brain metastasis
(13) pregnancy case
(14) unsuitable case

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takayama tetsuji

Organization

the univercity of tokushima

Division name

department of gastroenterology

Zip code


Address

3-18-15 kuramoto town tokushima city

TEL

088-633-9116

Email

takayama@tokushima-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name takayama tetsuji

Organization

the university of tokushima

Division name

department of gastroenterology

Zip code


Address

3-18-15 kuramoto town tokushima city

TEL

088-633-9116

Homepage URL


Email

takayama@tokushima-u.ac.jp


Sponsor or person

Institute

the university of tokushima

Institute

Department

Personal name



Funding Source

Organization

the university of tokushima

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

2014 Year 01 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

Open public recruiting

Date of protocol fixation

2014 Year 01 Month 27 Day

Date of IRB


Anticipated trial start date

2014 Year 01 Month 27 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

2014 Year 01 Month 27 Day

Last modified on

2014 Year 01 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015149


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name