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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000009865
Receipt No. R000011559
Scientific Title Clinical trial of TS-1 + CDDP + Trastuzumab-3 weekly cycle in HER2-positive advanced gastric cancer
Date of disclosure of the study information 2013/02/01
Last modified on 2014/09/17

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Basic information
Public title Clinical trial of TS-1 + CDDP + Trastuzumab-3 weekly cycle in HER2-positive advanced gastric cancer
Acronym Clinical trial of TS-1 + CDDP + Trastuzumab-3 weekly cycle
Scientific Title Clinical trial of TS-1 + CDDP + Trastuzumab-3 weekly cycle in HER2-positive advanced gastric cancer
Scientific Title:Acronym Clinical trial of TS-1 + CDDP + Trastuzumab-3 weekly cycle
Region
Japan

Condition
Condition HER2 positive advanced gastric cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of TS-1 + cisplatin + Trastuzumab 3-weekly schedule regimen for advanced gastric cancer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Progression-free survival (PFS)
Key secondary outcomes Safety
Overall survival (OS)
Response rate (RR)

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 po on Days 1-14
Cisplatin : 60mg/m2 iv on Day 1
Trastuzumab : 8mg/kg iv on Day 1 (fist course), and 6mg/kg iv on Day 1 (from second course)
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1. Histologically confirmed gastric cancer.
2. Patients who have HER2-positive cancer confirmed with IHC and/or FISH (IHC 3+ or IHC 2+ and FISH positive).
3. Age 20-80
4. Performance status (ECOG scale) 0
or 1.
5. No prior chemotherapy or radiotherapy for gastric cancer. Patients who received S-1+CDDP therapy until having diagnosed HER2-positive
6. Patients without brain metastasis.
7. Adequate baseline organ and marrow function as defined below;
a. Leukocytes : 3,500-12,000/mm3
b. Absolute neutrophil count : >= 2,000/mm3
c. Platelets : >= 100,000/mm3
d. Hemoglobin : >= 9.0g/dL
e. AST (SGOT)/ALT (SGPT) : < 100IU/L
f. Total bilirubin : < 1.5mg/dL
g. Serum creatinine : <= 1.2mg/dL
h. Creatinine clearance : >= 60mL/min
8. Patients with left ventricular ejection fraction of at least 50% on MUGA (Multi Gated Acquisition Scan) or echocardiography done within 21 days before enrollment.
9. No abnormal findings requiring treatment in the electrocardiogram within 21 days before enrollment.
10. Patients able to take orally.
11. Patients should sign a written informed consent.
Key exclusion criteria 1. Patients who are contraindicated to S-1, CDDP, and Trastuzumab.
2. Women in pregnancy, at risk of pregnancy, hoping to become pregnant. Men who want their partners to become pregnant.
3. Patients with active infection.
4. Patients have Active hepatitis type B.
5.Serious illness or medical conditions as defined below;
a. Patient with a previous history of congestive heart failure
b. Hi-risk uncontrolled arrhythmias
c. Unstable angina requiring medication
d. Patient with a previous history of myocardial infarction
e. Severe heart valve disease
f. Patient with a previous history of transmural infarct
g. Uncontrolled hypertension
6. Serious complication as followings ;
a. Interstitial pneumonia
b. Pulmonary fibrosis
c. Heart failure
d. Renal failure
e. Hepatic failure
f. Uncontrolled diabetes mellitus
7. Patients with fresh bleeding from gastric cancer and/or the digestive tract
8. Patients with diarrhea (4 or more times per day or watery diarrhea).
9.Second primary malignancy (except adequately treated basal cell carcinoma treated more than 5 years ago without recurrence)
10. Patients who are received systemic continuous administration of flucytosine, phenytoin, or warfarin.
11. Any patients judged by the investigator to be unfit to participate in the study.
Target sample size 8

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keiichi Kubota
Organization Dokkyo Medical University
Division name Second Department of Surgery
Zip code
Address 880 Kitakobayashi, Mibu, Tochigi, Japan
TEL 0282-87-2158
Email kubotak@dokkyomed.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akihito Abe
Organization Dokkyo Medical University
Division name Second Department of Surgery
Zip code
Address 880 Kitakobayashi, Mibu, Tochigi, Japan
TEL 0282-87-2158
Homepage URL
Email abe.surge@gmail.com

Sponsor
Institute Dokkyo Medical University
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 02 Month 01 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 Open public recruiting
Date of protocol fixation
2012 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 09 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
2013 Year 01 Month 24 Day
Last modified on
2014 Year 09 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011559

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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