UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009865 |
|---|---|
| Receipt number | 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 14:29:36 |
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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
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
abe.surge@gmail.com
Sponsor or person
Institute
Dokkyo Medical 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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011559
