UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000123
Receipt number R000000183
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)
Date of disclosure of the study information 2005/09/07
Last modified on 2014/02/21 14:19:28

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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 or person

Institute

Japan Clinical Oncology Group(JCOG)

Institute

Department

Personal name



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

Value
https://center6.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