UMIN-CTR Clinical Trial

Basic information
Public title	Randomized phase III study of 5-FU continuous infusion (5FUci) versus MTX+5-FU sequential therapy (MF) in gastric cancer with peritoneal metastasis (JCOG0106-MF, MF/5FU)
Acronym	Randomized phase III study of 5-FU versus MTX+5-FU in gastric cancer with peritoneal metastasis (JCOG0106-MF, MF/5FU)
Scientific Title	Randomized phase III study of 5-FU continuous infusion (5FUci) versus MTX+5-FU sequential therapy (MF) in gastric cancer with peritoneal metastasis (JCOG0106-MF, MF/5FU)
Scientific Title:Acronym	Randomized phase III study of 5-FU versus MTX+5-FU in gastric cancer with peritoneal metastasis (JCOG0106-MF, MF/5FU)
Region	Japan

Condition
Condition	gastric cancer with peritoneal metastasis
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To develop effective chemotherapy regimen agasinst gastric cancer with peritoneal metastasis
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase III

Assessment
Primary outcomes	overall survival
Key secondary outcomes	oral intake, toxicity

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	A: 5-FU continuous infusion
Interventions/Control_2	B: MTX+5-FU sequential therapy
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) histologic confirmation of gastric adenocarcinoma (2) inoperable metastatic disease or recurrent metastatic disease after surgery (3) disease with peritoneal metastasis (4) 20 years or more but less than 75 years (5) performance status 2 or less on the Eastern Cooperative Oncology Group scale (6) no prior treatment for gastric carcinoma except for surgery and adjuvant chemotherapy (7) no prior chemotherapy or radiotherapy for other disease except for gastric cancer (8) adequate bone marrow function, adequate liver function, and adequate renal function (9) no prior transfusion for anemia (10) provision of written informed consent
Key exclusion criteria	(1) Massive pleural effusion (2) brain metastasis with symptoms (3) severe diarrhea (4) other severe medical conditions (infection, diabetes, hypertension, acute myocardial infarction, unstable angina, liver cirrhosis, intestinal pneumonia, pulmonary fibrosis) (5) other active malignancies
Target sample size	236

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kuniaki Shirao, MD,PhD
Organization	National Cancer Center Hospital
Division name	Gatrointestinal Oncology Division
Zip code
Address	5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045 JAPAN
TEL
Email

Public contact
Name of contact person	1st name Middle name Last name Kuniaki Shirao, MD,PhD
Organization	JCOG0106 coordinating Office
Division name	Gatrointestinal Oncology Division, National Cancer Center Hospital
Zip code
Address	5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045 JAPAN
TEL
Homepage URL	http://www.jcog.jp/
Email	JCOG_sir@ml.jcog.jp

Sponsor
Institute	Japan Clinical Oncology Group(JCOG)
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	YES
Study ID_1	NCT00149201
Org. issuing International ID_1	ClinicalTrials.gov by NLM
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions

Institutions

北海道大学医学部（北海道） 斗南病院（北海道） 青森県立中央病院（青森県） 岩手県立中央病院（岩手県） 東北大学医学部（宮城県） 山形県立中央病院（山形県） 茨城県立中央病院・茨城県立地域がんセンター（茨城県） 栃木県立がんセンター（栃木県） 埼玉県立がんセンター（埼玉県） 埼玉医科大学病院（埼玉県） 国立がんセンター東病院（千葉県） 千葉県がんセンター（千葉県） 総合病院国保旭中央病院（千葉県） 国立がんセンター中央病院（東京都） 昭和大学病院（東京都） 癌研究会有明病院（東京都） 北里大学東病院（神奈川県） 神奈川県立がんセンター（神奈川県） 横浜市立市民病院（神奈川県） 横浜市立大学医学部附属市民総合医療センター（神奈川県） 佐久総合病院（長野県） 静岡県立静岡がんセンター（静岡県） 愛知県がんセンター中央病院（愛知県） 国立病院機構名古屋医療センター（愛知県） 愛知県がんセンター愛知病院（愛知県） 京都大学医学部附属病院（京都府） 大阪医科大学（大阪府） 神戸大学医学部（兵庫県） 兵庫県立成人病センター（兵庫県） 国立病院機構四国がんセンター（愛媛県） 高知医療センター（高知県） 国立病院機構九州がんセンター（福岡県） 九州大学病院（福岡県） 熊本地域医療センター（熊本県）

Other administrative information
Date of disclosure of the study information	2005 Year 09 Month 07 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	http://www.ncbi.nlm.nih.gov/pubmed/24014884
Number of participants that the trial has enrolled
Results	See the datails via "URL releasing results" above. Also the details can be seen in the JCOG website: http://www.jcog.jp/en/trials/index.html
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	Completed
Date of protocol fixation	2002 Year 01 Month 07 Day
Date of IRB
Anticipated trial start date	2002 Year 10 Month 01 Day
Last follow-up date	2008 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2010 Year 04 Month 01 Day

Other
Other related information

Management information
Registered date	2005 Year 09 Month 07 Day
Last modified on	2014 Year 02 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000183

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

Contact us.