UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective observational study on the efficacy and safety of EPA in advanced gastric cancer patients treated by S-1+CDDP as first line.
Title of the study (Brief title)	Prospective observational study on the efficacy and safety of EPA in advanced gastric cancer patients treated by S-1+CDDP as first line.
Region	Japan

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

Objectives
Narrative objectives1	This study will evaluate the efficacy and safety of EPA in combination with S-1+CDDP for patients with advanced gastric cancer. In addition, early diagnosis method of cancer cachexia is considered exploratory.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	time to treatment failure(TTF) of a first-line chemotherapy
Key secondary outcomes	rate of weight loss, alteration in nutritional status, alteration in Glasgow Prognostic score, QOL(Quality of life), adverse events, progression free survival, response rete, relative dose intense, translational research

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	icosapentaenoic acid (EPA)
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)Patients with clinically(radiographically/histologically/cytologically)proved adenocarcinoma of advanced gastric cancer and esophagogastric cancer (2)Patients who can intake orally (3)Patients without pretreatment for gastric cancer (4)Patients without previous chemotherapy for malignant tumor except for gastric cancer and radiation therapy to the abdominal legion (5)Patients with assessable lesion as defined by the Recist ver1.1 criteria (6)20-75 year-old at informedconsent (7)ECOG performance status(PS) 0-2 (8)Adequate bone marrow and organ function as defined as below -leukocyte count>=3000/mm3 -neutrophil count>=1500/mm3 -hemoglobin level>=8.0g/dL -platelet count>=100000/mm3 -AST and ALT=<100IU/L or AST and ALT=<200IU/L with liver metastases -total bilirubin=<1.5mg/dL -serum creatinin=<upper limit of average level in each facility, creatinin clearance>=50ml/min (10)Written informed consent obtained from patients
Key exclusion criteria	(1)Patients with active bleeding or beedingtendency (2)Patients who receive anticoagulant or antiplatelet drug (3)Patients without prior therapy with drugs or supplements contained icosapentaenoic acid (4)Patients with a history of allergy to icosapentaenoic acid (5)Patients scheduled for surgery (6)Patients scheduled for immune therapy (7)Patients with serious complication (8)Patients with immune-mediated illness (9)Patients with digestive symptom by ileus or gastrointestinal bleeding (10)Patients with symptomatic brain metastases or carcinomatous meningitis (11)Patients with massive pericardial effusion, pleural effusion or ascites *except for patients if effusions and ascites did not accumulate for more than two weeks after dranage therapy *include patients if pleurosclerosis was performed with anticancer drugs except OK-432 (12)Metachronous and synchronous double cancer (13)Bood tests positive for HBs antigen (14)Patients who receive continuous corticosteroid administration (15)Patients who receive drugs interact with S-1 or cisplatin (16)Uncontrolled psychiatry disease (17)Pregnant or lactating female and men who want to get partner pregnant (18)Judged inappropriate by the investigators
Target sample size	30

Research contact person
Name of lead principal investigator	Keita Uchino
Organization	Kyushu medical center
Division name	medical oncology
Address	1-8-1 Jigyouhama, Chuo-ku, Fukuoka 810-8563, Japan
TEL	092-852-0700
Email	keitauch@kyumed.jp

Public contact
Name of contact person	Kotoe Takayoshi
Organization	Kyushu medical center
Division name	medical oncology
Address	1-8-1 Jigyouhama, Chuo-ku, Fukuoka 810-8563, Japan
TEL	092-852-0700
Homepage URL
Email	t-kotoe@kyumed.jp

Sponsor
Institute	Kyushu medical center, medical oncology
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	九州医療センター Kyushu medical center

Other administrative information
Date of disclosure of the study information	2015 Year 01 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 12 Month 18 Day
Anticipated trial start date	2013 Year 12 Month 18 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	2015 Year 01 Month 15 Day
Last modified on	2017 Year 11 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018146