UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase I trial of capecitabine, oxaliplatin and irinotecan combination chemotherapy (XELOXIRI) for advanced gastric cancer
Title of the study (Brief title)	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	Eishi Baba
Organization	Kyushu University Faculty of Medical Sciences
Division name	Department of Conprehensive Clinical Oncology
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	Shingo Tamura
Organization	Kyushu Medical Center
Division name	Department of Clinical Oncology
Address	1-8-1 Jigyohama, Chuo-ku, Fukuoka city, Fukuoka, Japan
TEL	092-852-0700
Homepage URL
Email	tamshin@me.com

Sponsor
Institute	Kyushu University
Institute
Department

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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 05 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026251