UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	PhaseII study of mFOLFOX6 in gastric cancer refractory to standard therapy
Title of the study (Brief title)	PhaseII study of mFOLFOX6 in gastric cancer refractory to standard therapy
Region	Japan

Condition
Condition	Gastric cancer
Classification by specialty	Gastroenterology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety and efficacy of mFOLFOX6 in gastric cancer refractory to standard therapy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Response rate assessed by independent review committee
Key secondary outcomes	Disease control rate, progression free survival, overall survival, adverse events, quality of life

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	mFOLFOX6
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Histologically confirmed adenocarcinoma of gastric or esophagogastric junction. 2) Presence of inoperable recurrent or metastatic disease. 3) Received fluoropirimidines, cisplatin and either taxanes and irinotecan before as anticancer treatment for advanced gastric cancer. 4) Male or female patients >=20 years old at the time of informed consent. 5) ECOG performance status of 0 or 1. 6) Presence of at least one measurable disease as defined by RECIST version 1.1. 7) Written informed consent.
Key exclusion criteria	1) Patients with symptomatic brain metastases. 2) Requires perodial drainage of pleural fluid, ascites or pericardial effusion. 3) Received chemotherapy, radiotherapy, surgical or any other experimental therapies as anticancer treatment within 14 days before the first administration of this trial. 4) Previous treatment with oxaliplatin. 5) Concurrent uncontrolled medical condition including active infection, hypertension, diabetes mellitus, pulmonary, cardiac or psychiatric disease 5) known or suspected of not being able to comply with this trial protocol.
Target sample size	35

Research contact person
Name of lead principal investigator	Shigenori Kadowaki
Organization	Aichi Cancer Center Hospital
Division name	Department of Clinical Oncology
Address	1-1 Kanokoden, Chikusa-ku, Nagoya, Japan
TEL	052-762-6111
Email	skadowaki@aichi-cc.jp

Public contact
Name of contact person	Seiichiro Mitani
Organization	Aichi Cancer Center Hospital
Division name	Department of Clinical Oncology
Address	1-1 Kanokoden, Chikusa-ku, Nagoya, Japan
TEL	052-762-6111
Homepage URL
Email	smitani@aichi-cc.jp

Sponsor
Institute	Aichi Cancer Center Hospital
Institute
Department

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)

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	2015 Year 02 Month 02 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 01 Month 26 Day
Anticipated trial start date	2015 Year 02 Month 02 Day
Last follow-up date	2018 Year 03 Month 11 Day
Date of closure to data entry
Date trial data considered complete	2018 Year 03 Month 11 Day
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 02 Month 02 Day
Last modified on	2018 Year 03 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019063