UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009565 |
|---|---|
| Receipt number | R000010482 |
| Scientific Title | Pilot study of S-1/Paclitaxel/Trastuzumab combination chemotherapy for HER2-positive Stage IV advanced gastric cancer. |
| Date of disclosure of the study information | 2012/12/17 |
| Last modified on | 2012/12/17 14:43:42 |
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Basic information
Public title
Pilot study of S-1/Paclitaxel/Trastuzumab combination chemotherapy for HER2-positive Stage IV advanced gastric cancer.
Acronym
KGCSG1201
Scientific Title
Pilot study of S-1/Paclitaxel/Trastuzumab combination chemotherapy for HER2-positive Stage IV advanced gastric cancer.
Scientific Title:Acronym
KGCSG1201
Region
| Japan |
Condition
Condition
HER2-positive Stage IV advanced gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the efficacy and safety of S-1/Paclitaxel/Trastuzumab combination chemotherapy as 1st line therapy on HER2-positive Stage IV advanced gastric cancer.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Safety
Key secondary outcomes
Overall survival,Progression-free-survival,Response Rate
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
S-1/Paclitaxel/Trastuzumab combination chemotherapy
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) Histologically proven advanced gastric cancer.
2) Positive HER2 status(IHC3+ or IHC2+/FISH+)
3) Age of 20 years or older.
4) Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
5) Without previous medication history for advanced gastric cancer.
6) Patient who has more than one measurable or evaluable lesion.
7) Patient who is possible of ingestion.
8) Adequate organ function.
*WBC count 3,500-12,000/mm3
*Neutrophils count more than 2,000/mm3
*Platelet count more than 100,000/mm3.
*Hemoglobin more than 8.0 g/dl.
*Total bilirubin level less than 1.5 mg/dl
*AST and ALT less than 100 IU/l
*Creatinine clearance more than 60mL/min
9) LVEF more than 50% within 28 days.
10) Electrocardiogram was performed within 28 days.
11) Life expectancy of at least 3 months after registration.
12) Written informed conscent to receive this chemotherapy.
Key exclusion criteria
1)Forbidden case to use S-1, Paclitaxel and Trastuzumab.
2)Patient who want to be pregnant and /or pregnant woman. Intend to make pregnant.
3)Infection or inflammatory case.
4)Active hepatitis type HBs positive.
5)Severe heart disease.
6)Severe complicated case.
7)Watery diarrhea.
8)Bleeding from tumor or ulceration.
9)Multiple bone metastasis.
10)Clinical suspicion or previous history of metastasis to brain or meninges.
11)Complicated other active cancer.
12)Operated within 28 days.
13)Mental disability requiring medical treatment.
14)Otherwise determined by investigators or site principal investigators to be unsuitable for participation in study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Syoji Natsugoe |
Organization
Graduate School of Medical Science Kagoshima University
Division name
Department of Digestive Surgery, Breast and Thyroid Surgery
Zip code
Address
8-35-1 Sakuragaoka, kagoshima city, kagoshima
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sumiya Ishigami |
Organization
Graduate School of Medical Sciences Kagoshima University
Division name
Department of Digestive Surgery, Breast and Thyroid Surgery
Zip code
Address
8-35-1 Sakuragaoka, kagoshima city, kagoshima
TEL
Homepage URL
Sponsor or person
Institute
Department of Digestive Surgery, Breast and Thyroid Surgery
Graduate School of Medical Science
Kagoshima University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
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
| 2012 | Year | 12 | Month | 17 | 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
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 11 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 12 | Month | 17 | Day |
Last modified on
| 2012 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010482
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
