UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011595 |
|---|---|
| Receipt number | R000013557 |
| Scientific Title | Phase II Study of combination chemotherapy with SPT in patient with HER2(+) advanced gastric cancer |
| Date of disclosure of the study information | 2013/08/28 |
| Last modified on | 2013/08/28 10:09:58 |
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Basic information
Public title
Phase II Study of combination chemotherapy with SPT in patient with HER2(+) advanced gastric cancer
Acronym
KGCG-01
Scientific Title
Phase II Study of combination chemotherapy with SPT in patient with HER2(+) advanced gastric cancer
Scientific Title:Acronym
KGCG-01
Region
| Japan |
Condition
Condition
HER2(+) advanced gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of TS-1 + cisplatin + Trastuzumab for HER2(+) advanced gastric cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Response rate
Key secondary outcomes
Progression-free survival
Overall survival
Time to treatment failure
Safety
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
TS-1:80mg/m2/day day1-14
CDDP:60mg/m2 day1
Trastuzumab:8mg/kg day1 (from second course 6mg/kg)
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 confirmed unresectable or recurrent gastric adenocarcinoma
2) Patients who have HER2-positive cancer confirmed with IHC and/or FISH (IHC 3+ or IHC 2+ and FISH positive)
3) unresecrable or advanced gastric cancer
4) Patients who have measurable region defined by RECIST version 1.1 within 28 days before enrollment
5) No prior chemotherapy or radiotherapy for gastric cancer
6) Performance status (ECOG scale) 0
or 1
7) Age 20-
8) Patients without the evidence of clear peritoneal metastases
9) Patients able to take orally
10) Adequate baseline organ and marrow function
11) No abnormal findings requiring treatment in the electrocardiogram within 21 days before enrollment
12) Patients should sign a written informed consent
Key exclusion criteria
1) Patients with a history of serious drug hypersensitivity
2) Patients who are received administration of flucytosine
3) Patients who are received continuous administration of phenytoin, or warfarin.
4) Patients with active infection
5) Patients with serious complication
6) Patients with diarrhea (4 or more times per day or watery diarrhea)
7) Patients with massive ascites or massive pleural effusion retention.
8) Patients with serious heart disease
9) Uncontrolled hypertension
10) Second primary malignancy
11) Women in pregnancy, at risk of pregnancy, hoping to become pregnant
12) Men who want their partners to become pregnant
13) Any patients judged by the investigator to be unfit to participate in the study
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideyuki Suzuki |
Organization
Nippon Medical School Musasikosugi Hospital
Division name
Digestive Disease Center
Zip code
Address
1-396 Kosugicho, Nakahara-ku, Kawasaki-city, 211-8533, Japan
TEL
044-733-5181
pdd00576@nifty.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideki Bou |
Organization
Nippon Medical School Musasikosugi Hospital
Division name
Digestive Disease Center
Zip code
Address
1-396 Kosugicho, Nakahara-ku, Kawasaki-city, 211-8533, Japan
TEL
044-733-5181
Homepage URL
bou@nms.ac.jp
Sponsor or person
Institute
Kawasaki Gastric Cancer Group(KGCG)
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
| 2013 | Year | 08 | Month | 28 | 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
| 2012 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 08 | Month | 28 | Day |
Last modified on
| 2013 | Year | 08 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013557
