UMIN-CTR Clinical Trial

Public title

A phase2 study of trastumab and TS-1 for HER2-positive advanced gastric cancer

Acronym

trastumab and TS-1 for HER2-positive advanced gastric cancer

Scientific Title

A phase2 study of trastumab and TS-1 for HER2-positive advanced gastric cancer

Scientific Title:Acronym

trastumab and TS-1 for HER2-positive advanced gastric cancer

Region

Japan

Condition

Gastric Cancer

Classification by specialty

Surgery in general	Gastrointestinal surgery	Adult

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

The aim of this study is elucidate the anticancer efficacy and feasibility of TS-1 and trastuzumab combination therapy for HER2-positive advanced gastric cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

Progression-free survival

Key secondary outcomes

Overall survival
Response rate
Adverse event

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

TS-1 orally in 2 divided doses for 2weeks on and 1week rest
trastuzumab intravenously on day1 of every 3weeks

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Histologically confirmed gastric adenocarcinoma with unresectable metastatic or recurrent disease
2) Positive HER2 status
3) Lesions confirmed on imaging within 28 days before registration
4) No previous chemotherapy or radiotherapy. However, adjuvant chemotherapy is allowed the case of more than 6 months from the end of adjuvant chemotherapy
5) ECOG Performance Status of 0 to 2
6) Adequate Major organ functions within 14 days before registration
7) Life expectancy of at least 3 months after registration
8) Written informed consent
9) Age of 20 to 74 years with either gender

Key exclusion criteria

1) Past history of drug allergy
2) Women who are pregnant, breastfeeding, or potentially (hoping to become) pregnant
3) R1 operation(histlogically positive PM, OM, LM, VM )
4) Being treated or in need of treatment with flucytosine, phenytoin or warfarin potassium
5) Patient with clinically obvious
infecton
6) Past history of drug allergy of
S-1, CDDP and Trastuzumab
7) Heart disease that is serious or requires hospitalization, or history of such disease within past year
8) Chronic diarrhea (watery stool or 4 times or more/day)
9) Massive ascites
10) Multiple bone metastasis
11) Clinical suspicion or previous history of metastasis to brain or meninges
12) Operation within 28day
13) More than one cancer at the same time or more than one cancer at different times separated by a 5-year disease-free interval. However, multiple active cancers do not include carcinoma in situ or skin cancer which is determined to have been cured as a result of treatment.
14,15) Difficulty to join the trial due to
psychosis or psychotic symptoms or
central nervous system damage
16) requiring steroid drug
17) Active hepatitis type HBs positive
18) Otherwise determined by investigators or site principal investigators to be unsuitable for participation in study

Target sample size

20

Name of lead principal investigator

1st name
Middle name
Last name	Noriyuki Hirahara, M.D., Ph.D.

Organization

Shimane University Hospital

Division name

Digestive and General Surgery

Zip code

Address

89-1, Enya-cho, Izumo, Shimane, 693-8501, Japan

TEL

0853-20-2232

Email

norinori@med.shimane-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Noriyuki Hirahara, M.D., Ph.D.

Organization

Shimane University Hospital

Division name

Digestive and General Surgery

Zip code

Address

89-1, Enya-cho, Izumo, Shimane, 693-8501, Japan

TEL

0853-20-2232

Homepage URL

Email

norinori@med.shimane-u.ac.jp

Institute

Shimane University Hospital

Institute

Department

Personal name

Organization

Shimane University Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

none

Name of secondary funder(s)

none

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

島根大学病院（島根県）、島根県立中央病院（島根県）、雲南市立病院（島根県）、出雲市立総合医療センター（島根県）、浜田医療センター（島根県）、松江赤十字病院（島根県）、松江生協病院（外科）、益田医師会病院（島根県）、町立奥出雲病院（島根県）

Date of disclosure of the study information

2011

Year

08

Month

04

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Open public recruiting

Date of protocol fixation

2011

Year

06

Month

24

Day

Date of IRB

Anticipated trial start date

2011

Year

08

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2011

Year

08

Month

04

Day

Last modified on

2014

Year

02

Month

05

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007232