UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014471
Receipt number R000016835
Scientific Title A phase I/II study of chemotherapy using S-1, Oxaliplatin plus Irinotecan for unresectable pancreatic cancer
Date of disclosure of the study information 2014/07/07
Last modified on 2015/03/23 18:42:02

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

A phase I/II study of chemotherapy using S-1, Oxaliplatin plus Irinotecan for unresectable pancreatic cancer

Acronym

A phase I/II study of chemotherapy for unresectable pancreatic cancer

Scientific Title

A phase I/II study of chemotherapy using S-1, Oxaliplatin plus Irinotecan for unresectable pancreatic cancer

Scientific Title:Acronym

A phase I/II study of chemotherapy 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



Assessment

Primary outcomes

PhaseI: MTD, RD
Phase II: response rate

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

S-1: dose escalation
L-OHP: fixed dose
Irinotecan: 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 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 S-1, L-OHP and Irinotecan
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

2-1-1 Asamizodai Minami Sagamihara Kanagawa 252-0380 Japan

TEL

+81-42-478-9111

Email

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

2-1-1 Asamizodai Minami Sagamihara Kanagawa 252-0380 Japan

TEL

+81-42-478-9111

Homepage URL


Email

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


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 07 Month 07 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

2014 Year 06 Month 02 Day

Date of IRB


Anticipated trial start date

2014 Year 07 Month 10 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 07 Month 03 Day

Last modified on

2015 Year 03 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016835


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name