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

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 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


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

Value
https://center6.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