UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008220
Receipt number R000009687
Scientific Title A Phase II study of combination chemotherapy with TS-1 and Trastuzumab for patients with HER2 positive advanced or recurrent gastric cancer.
Date of disclosure of the study information 2012/06/20
Last modified on 2017/10/27 15:47:36

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Basic information

Public title

A Phase II study of combination chemotherapy with TS-1 and Trastuzumab for patients with HER2 positive advanced or recurrent gastric cancer.

Acronym

STAR study

Scientific Title

A Phase II study of combination chemotherapy with TS-1 and Trastuzumab for patients with HER2 positive advanced or recurrent gastric cancer.

Scientific Title:Acronym

STAR study

Region

Japan


Condition

Condition

advanced or recurrent gastric cancer

Classification by specialty

Gastroenterology Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate feasibility, safety and efficacy of TS-1 + Trastuzumab for HER2-positive advanced gastric cancer .

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase II


Assessment

Primary outcomes

treatment completion ratio

Key secondary outcomes

respons rete, 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

Drug:TS-1 and Trastuzumab
TS-1:80mg/m2 on Day 1-28
Trastuzumab:6mg/kg on Day 1 and Day 22 (first time: 8mg/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) Histopathological confirmation of Adenocarcinoma
2) Unresectable or recurrent gastric cancer
3) Previously-treated patient
4) HER2-positive tumor
5) Age 20
6) ECOG performance status of 0 to 2
7) Adequate organ function as follows:
1.Neu : >= 1,500 /mm3
2.Platelet : >= 100,000 /mm3
3.hemoglobin : >= 9.0 g/dL
4.AST, ALT : < 100 IU/L
5.St.bil : < 1.5 mg/dL
6.Serum creati : <= 1.2 mg/dL
7.Ccr : >= 60 ml/min
8) Ejection fraction more than 50% by ultrasound or MUGA
9) Normal electrocardiogram which was performed within 21 days
10) Sufficient oral intake
11) Expected more than 3 months survival
12) Written informed consent

Key exclusion criteria

1) Prior chemotherapy of TS-1
2) With severe allergy to TS-1 and Trastuzumab
3) Women in pregnancy, at risk of pregnancy, hoping to become pregnant. Men who want their partners to become pregnant.
4) Active infection and inflammation.
5) History of cardiac disease
6) Patients with Severe complications
7) Patients with resting dyspnea
8) Patients with gastrointestinal ulceration and bleed
9) Patients with diarrhea (4 or more times per day or watery diarrhea).
10) Massive pleural or abdominal effusion
11) Patients with metastasis to CNS
12) synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ
13) Patients under treatment with flucytosine, phenytoin or warfarin potassium
14) Patients who are received systemic administration of corticosteroid.
15) Other patients who are unfit for the study as determined by the attending physician.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Naotoshi Sugimoto

Organization

Osaka medical center for cancer and cardiovascular diseases

Division name

Department of Clinical Oncology

Zip code


Address

1-3-3 Nakamichi, Higashinari-ku, Osaka

TEL

06-6972-1181

Email

sugimoyo-na2@mcpref.osaka.jp


Public contact

Name of contact person

1st name
Middle name
Last name Naotoshi Sugimoto

Organization

Osaka medical center for cancer and cardiovascular diseases

Division name

Department of Clinical Oncology

Zip code


Address

1-3-3 Nakamichi, Higashinari-ku, Osaka

TEL

06-6972-1181

Homepage URL


Email

sugimoyo-na2@mcpref.osaka.jp


Sponsor or person

Institute

Osaka medical center for cancer and cardiovascular diseases

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

2012 Year 06 Month 20 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

Terminated

Date of protocol fixation

2012 Year 01 Month 12 Day

Date of IRB


Anticipated trial start date

2012 Year 02 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

2012 Year 06 Month 20 Day

Last modified on

2017 Year 10 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009687


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name