UMIN-CTR Clinical Trial

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

gastric cancer with peritoneal metastasis

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO

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

Primary outcomes

overall survival

Key secondary outcomes

oral intake, toxicity

Study type

Interventional

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

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

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

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

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

Institute

Japan Clinical Oncology Group(JCOG)

Institute

Department

Personal name

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

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

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）

Date of disclosure of the study information

2005

Year

09

Month

07

Day

URL releasing protocol

Publication of results

Published

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

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 related information

Registered date

2005

Year

09

Month

07

Day

Last modified on

2014

Year

02

Month

21

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000183