UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000062
Receipt number R000000107
Scientific Title Randomized phase III study of 5-FU continuous infusion (5-FUci) versus CPT-11 plus CDDP (CP) versus S-1 alone (S-1) in advanced gastric cancer (JCOG9912)
Date of disclosure of the study information 2005/08/16
Last modified on 2014/02/21 13:57:34

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Basic information

Public title

Randomized phase III study of 5-FU continuous infusion (5-FUci) versus CPT-11 plus CDDP (CP) versus S-1 alone (S-1) in advanced gastric cancer (JCOG9912)

Acronym

Randomized phase III study of 5-FU continuous infusion (5-FUci) versus CPT-11 plus CDDP (CP) versus S-1 alone (S-1) in advanced gastric cancer (JCOG9912)

Scientific Title

Randomized phase III study of 5-FU continuous infusion (5-FUci) versus CPT-11 plus CDDP (CP) versus S-1 alone (S-1) in advanced gastric cancer (JCOG9912)

Scientific Title:Acronym

Randomized phase III study of 5-FU continuous infusion (5-FUci) versus CPT-11 plus CDDP (CP) versus S-1 alone (S-1) in advanced gastric cancer (JCOG9912)

Region

Japan


Condition

Condition

advanced or recurrent gastric cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To invstigate the superiority of a combination of irinotecan and cispoatin and the non-inferiority of S-1 compared to continuous infusion of 5-FU in advanced gastric cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Phase III


Assessment

Primary outcomes

overall survival

Key secondary outcomes

time to treatment failure, incidences of adverse events, response rate, non-hospitalized survival


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

3

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

continuous infusion of 5-fluorouracil

Interventions/Control_2

combination of irinotecan and cisplatin

Interventions/Control_3

oral administration of S-1

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) unresectable or recurrent histologically proved gastric cancer
2) adequate oral intake
3) age 20 or older and 75 or younger
4) Performance Status (ECOG):0, 1, 2
5) measurable or unmeasurable lesions
6) preserved organ functions
7) no esvere medical condition
8) no prior chemotherapy for gastric cancer
9) written informed consent

Key exclusion criteria

1) patient with marked infection or inflammation
2) patient with severe peritoneal metastasis
3) patient with massive plueral effusion
4) patient with metastasis to CNS
5) patiet with diarrhea 4 or more times per day
6) patient severe medical condition
7) patient with other concurrent malignancy affecting on survival or adverse events
8) pregnant or nursing patient or with intent to bear baby
9) patient evaluated to be inadequate by a attending doctor
10) patient reqiring nutritional support

Target sample size

690


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Atsushi Ohtsu, MD

Organization

National Cancer Centr Hospital East

Division name

Div. of Gastrointestinal Oncology and Endoscopy

Zip code


Address

6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577 Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Narikazu Boku, MD

Organization

JCOG9912 Coordinating Office

Division name

Div. of Gastrointestinal Oncology, Shizuoka Cancer Center

Zip code


Address

1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777 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)

Taiho Pharmaceutical Co. Ltd., Yakult Honsha Co. Ltd.


IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

YES

Study ID_1

NCT00142350

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)
埼玉医科大学付属病院(埼玉県)
国立がんセンター東病院
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)
昭和大学附属病院(東京都)
癌研究会附属病院(東京都)
北里大学東病院(神奈川県)
横浜市立市民病院(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(愛知県)
名古屋医療センター(愛知県)
県立愛知病院(愛知県)
京都大学医学部付属病院(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)
四国がんセンター(愛媛県)
高知中央病院(高知県)
九州大学病院(福岡県)
熊本市地域医療センター(熊本県)
国立病院九州がんセンター(福岡県)
神奈川県立がんセンター(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)


Other administrative information

Date of disclosure of the study information

2005 Year 08 Month 16 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://www.ncbi.nlm.nih.gov/pubmed/19818685

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

2000 Year 09 Month 11 Day

Date of IRB


Anticipated trial start date

2000 Year 11 Month 01 Day

Last follow-up date

2007 Year 01 Month 01 Day

Date of closure to data entry

2007 Year 12 Month 01 Day

Date trial data considered complete

2007 Year 12 Month 01 Day

Date analysis concluded

2007 Year 12 Month 01 Day


Other

Other related information



Management information

Registered date

2005 Year 08 Month 16 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=R000000107


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name