UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022861
Receipt number R000026251
Scientific Title Phase I trial of capecitabine, oxaliplatin and irinotecan combination chemotherapy (XELOXIRI) for advanced gastric cancer
Date of disclosure of the study information 2016/06/24
Last modified on 2018/12/28 12:51:15

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Basic information

Public title

Phase I trial of capecitabine, oxaliplatin and irinotecan combination chemotherapy (XELOXIRI) for advanced gastric cancer

Acronym

Phase I trial of XELOXIRI for advanced gastric cancer

Scientific Title

Phase I trial of capecitabine, oxaliplatin and irinotecan combination chemotherapy (XELOXIRI) for advanced gastric cancer

Scientific Title:Acronym

Phase I trial of XELOXIRI for advanced gastric cancer

Region

Japan


Condition

Condition

Advanced gastric cancer

Classification by specialty

Gastroenterology Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To determine recommended dose of capecitabine, oxaliplatin, irinotecan combination chemotherapy (XELOXIRI)

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Dose limiting toxicity

Key secondary outcomes

objective response rate
disease control rate
adverse event


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

Combination chemotherapy with capecitabine, oxaliplatin and irinotecan. Oxaliplatin and irinotecan are administered on day1. Capecitabine is taken orally from day1 to day14. Increasing dose of irinotecan is administered when patients with dose limiting toxicity were fewer than the criteria.

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

70 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Histologically proven advanced / recurrent gastric cancer
2) Possible for oral intake and medication
3) Evaluable legions
4) No history of chemotherapy, immunotherapy or radiotherapy
5) ECOG performance status 0 or 1
6) No major complications
7) Written informed consent

Key exclusion criteria

1) HER2 positive
2) UGT1A1 *6 or *28 homozygote or *6 and *28 heterozygote
3) Symptomatic brain metastasis
4) Infectious disease
5) Grade 2 or more diarrhea
6) Grade 2 or more peripheral sensory neuropathy
7) Massive pleural effusion, ascites, or cardiac effusion
8) Ileus
9) Defined interstitial pneumonia

Target sample size

18


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Eishi Baba

Organization

Kyushu University Faculty of Medical Sciences

Division name

Department of Conprehensive Clinical Oncology

Zip code


Address

3-1-1 Maidashi, Higashi-ku, Fukuoka city, Japan

TEL

092-642-6921

Email

e-baba@intmed1.med.kyushu-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shingo Tamura

Organization

Kyushu Medical Center

Division name

Department of Clinical Oncology

Zip code


Address

1-8-1 Jigyohama, Chuo-ku, Fukuoka city, Fukuoka, Japan

TEL

092-852-0700

Homepage URL


Email

tamshin@me.com


Sponsor or person

Institute

Kyushu University

Institute

Department

Personal name



Funding Source

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Japanese Governmental office

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

2016 Year 06 Month 24 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

2016 Year 05 Month 30 Day

Date of IRB


Anticipated trial start date

2016 Year 06 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

2016 Year 06 Month 23 Day

Last modified on

2018 Year 12 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026251


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name