UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000067 |
|---|---|
| Receipt number | R000000110 |
| Scientific Title | Randomized trial of adjuvant chemotherapy with cisplatin followed by oral fluorouracil (UFT) in serosa-positive gastric cancer (JCOG9206-2) |
| Date of disclosure of the study information | 2005/08/18 |
| Last modified on | 2014/02/21 13:58:38 |
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Basic information
Public title
Randomized trial of adjuvant chemotherapy with cisplatin followed by oral fluorouracil (UFT) in serosa-positive gastric cancer (JCOG9206-2)
Acronym
Randomized trial of adjuvant chemotherapy with cisplatin followed by oral fluorouracil (UFT) in serosa-positive gastric cancer (JCOG9206-2)
Scientific Title
Randomized trial of adjuvant chemotherapy with cisplatin followed by oral fluorouracil (UFT) in serosa-positive gastric cancer (JCOG9206-2)
Scientific Title:Acronym
Randomized trial of adjuvant chemotherapy with cisplatin followed by oral fluorouracil (UFT) in serosa-positive gastric cancer (JCOG9206-2)
Region
| Japan |
Condition
Condition
gastric neoplasm
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the survival benefit of adjuvant chemotherapy after curative resection with D2 or greater lymph node dissection in T3-4 gastric cancer patients.
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
Relapse-free survival, the site of recurrence
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 | Maneuver |
Interventions/Control_1
Surgery (Gastrectomy with D2 or greater lymph node dissection)
Interventions/Control_2
Surgery + chemotherapy
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
| Not applicable |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Curative operation with D2 or greater lymph node dissection
(2) Histologically proven gastric adenocarcinoma
(3) Macroscopically serosa-positive (T3-4)
(4) No metastases to level 3 - 4 lymph nodes station (N0-2)
(5) 75 years or younger
(6) Negative peritoneal lavage cytology
(7) Adequate organ function
WBC >=4000/mm3, Hb >=11.0g/dl, Plt >=100.000/mm3, AST/ALT, T.Bil, BUN, Creatinine <=2.5 x Normal Upper Limit, Creatinine clearance <=70 ml/min
(8) Written informed consent
Key exclusion criteria
(1) Prior chemotherapy or radiotherapy
(2) Synchronous or metachronous malignancy in other organs
Target sample size
280
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Furukawa, MD, PhD |
Organization
Sakai Municipal Hospital
Division name
Surgery
Zip code
Address
1-1-1 Minamiyasui-cho, Sakai, Osaka 590-0064, JAPAN
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mitsuru Sasako, MD, PhD |
Organization
JCOG9206-2 Coordinating Office
Division name
Gastric Surgery 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/
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
Secondary IDs
Secondary IDs
YES
Study ID_1
NCT00147147
Org. issuing International ID_1
ClinicalTrials.gov by NLM
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2005 | Year | 08 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/21336855
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
| 1992 | Year | 12 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 1993 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2004 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2004 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2004 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2005 | Year | 01 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2005 | Year | 08 | Month | 18 | 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=R000000110
