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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000062
Receipt No. 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

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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
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) 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
URL(English) https://upload.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


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