UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	clinical evaluation trial about prediction of treatment effect of chemotherapy or chemoradiotherapy for gastrointestinal cancer using oxygen saturation imaging endoscopy
Title of the study (Brief title)	clinical evaluation trial using OSI endoscopy
Region	Japan

Condition
Condition	esophageal cancer, gastric cancer, and colorectal cancer
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To evaluate the clinical efficacy of oxygen saturation imaging endoscopy about prediction of treatment efficacy of chemotherapy or chemoradiotherapy for gastrointestinal cancer.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	correlation between oxygen saturation of tissue surface before chemotherapy or chemoradiotherapy evaluated with oxygen saturation imaging and treatment efficacy
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	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	oxygen saturation imaging
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) >= 20 years old. 2) ECOG performance status of <= 2. 3) Written informed consent. 4) The following treatments are scheduled for esophageal, gastric, or colorectal advanced cancer. a. Neoadjuvant chemotherapy with DCF regimen and surgery scheduled for esophageal cancer. b. Definitive chemoradiotherapy scheduled for esophageal cancer. c. Initial chemotherapy scheduled for unresectable gastric cancer. d. Initial chemotherapy scheduled for unresectable colorectal cancer.
Key exclusion criteria	1) Psychosis. 2) Ileus, obstruction or perforation of the digestive tract has been diagnosed or is suspected. 3) Active bacterial or fungal infection. 4) History of myocardial infarction or unstable angina pectoris within three months. 5) Ineligible judged by attending doctor.
Target sample size	70

Research contact person
Name of lead principal investigator	Tomonori Yano
Organization	National Cancer Center Hospital East
Division name	Department of Gastroenterology and Endoscopy
Address	6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL	04-7133-1111
Email	toyano@east.ncc.go.jp

Public contact
Name of contact person	Yusuke Yoda
Organization	National Cancer Center Hospital East
Division name	Department of Gastroenterology and Endoscopy
Address	6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL	04-7133-1111
Homepage URL
Email	yuyoda@east.ncc.go.jp

Sponsor
Institute	National Cancer Center Hospital East
Institute
Department

Funding Source
Organization	National Cancer Center
Organization
Division
Category of Funding Organization	Other
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	国立がん研究センター東病院（千葉県）

Other administrative information
Date of disclosure of the study information	2018 Year 02 Month 02 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 11 Month 16 Day
Anticipated trial start date	2018 Year 02 Month 02 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	2018 Year 02 Month 02 Day
Last modified on	2018 Year 02 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035528