UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006458 |
|---|---|
| Receipt number | R000007623 |
| Scientific Title | A Phase II study of capecitabine plus cisplatin (plustrastuzumab) for previously untreated advanced gastric cancer. |
| Date of disclosure of the study information | 2011/10/03 |
| Last modified on | 2023/04/11 11:13:22 |
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Basic information
Public title
A Phase II study of capecitabine plus cisplatin (plustrastuzumab)
for previously untreated advanced gastric cancer.
Acronym
A Phase II study of capecitabine plus cisplatin (plustrastuzumab)
for previously untreated advanced gastric cancer.
Scientific Title
A Phase II study of capecitabine plus cisplatin (plustrastuzumab)
for previously untreated advanced gastric cancer.
Scientific Title:Acronym
A Phase II study of capecitabine plus cisplatin (plustrastuzumab)
for previously untreated advanced gastric cancer.
Region
| Japan |
Condition
Condition
untreated advanced gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the safty and efficacy of capecitabine plus cispulatin(plus mainasu trastuzumab)for previously untreated advanced gastric cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
ORR:Overall ResponseRate
Key secondary outcomes
Safty
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
not
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Gastric cancer histologically ptoven adenocarcinoma included egjcancer
2)Presence of a measurable lesion for evaluation according to RECIST1.1
3)Without previous medication history such as radiation therapy chemotherapy and immunotherapy
4)Presence of HER2
5)LVEF more than50%
6)ECOG performance status of 0-2
7)Wrtten informed conscent to recieve this chemotherapy
8)More than 20 years old
9)Adequate organ function as follows
1,Neutrphilcountmorethan 1500mm3
2,Plateletcountmorethan 100000mm3
3,Hemoglobrin more than 9.0g/dl
4,AST,ALTwithin2.5thenormalupperlimits
5,ALP,ALTwithin2.5thenormalupperlimits
6,Serumbilirubinwithin1.5thenormalupperlimits
7,CCRmorethan60mL/min
Key exclusion criteria
1)Severe hypersensitivity to have a history fluorouracil,platinum,trastuzumab
2)Senere renal failure
3)Within seven days stop S-1(tegaful gimerasil oterasil)treatment
4)Intend to make pregnant
5)Others
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuji Wataneba |
Organization
Ehime University,School of Medicine
Division name
Gastrointestinal oncologysurgery
Zip code
Address
Shizukawa toon ,Ehime
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Ehime University,Shool of Medicine
Division name
Gastrointestinal oncologysurgery
Zip code
Address
TEL
089-960-5975
Homepage URL
Sponsor or person
Institute
Ehime University
Institute
Department
Personal name
Funding Source
Organization
non
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 10 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
Terminated
Date of protocol fixation
| 2011 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2011 | Year | 08 | Month | 31 | Day |
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 10 | Month | 03 | Day |
Last modified on
| 2023 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007623
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
