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
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/
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
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
