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UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000011595
Receipt No. 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

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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
Email 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
Email bou@nms.ac.jp

Sponsor
Institute Kawasaki Gastric Cancer Group(KGCG)
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013557

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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