UMIN-CTR Clinical Trial

Public title

S-1/trastuzumab for elderly HER2 positive
advanced gastric cancer-Pilot study-

Acronym

S-1/trastuzumab for elderly HER2 positive
advanced gastric cancer-Pilot study-

Scientific Title

S-1/trastuzumab for elderly HER2 positive
advanced gastric cancer-Pilot study-

Scientific Title:Acronym

S-1/trastuzumab for elderly HER2 positive
advanced gastric cancer-Pilot study-

Region

Japan

Condition

untreated HER2 positive advanced gastric cancer

Classification by specialty

Gastroenterology

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

YES

Narrative objectives1

Evaluation of the efficacy and safety of S-1 plus trastuzumab for elderly HER2 positive advanced gastric cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Primary outcomes

frequency and degree of adversed events

Key secondary outcomes

Overall survival, Progression free survival, Overall response rate

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

S-1+trastuzumab (S-1 80mg/m2 d1-28 and trastuzumab 8 or 6 mg/kg q3w)

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

75

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Non-curative resected or recurrent gastric cancer histologically proven adenocarcinoma
2) Without previous medication history
3) Eastern Cooperative Oncology Group (ECOG) performance status 0-1
4) 75 years old or more than 75 years old
5) Life expectancy of at least 3 months after registration
6) Positive HER2 status(IHC3+ or IHC2+/FISH+)
7) Adequate organ function
8) Patient who is possible of ingestion
9) LVEF more than 50%
10) Normal electrocardiogram which was performed within 21 days
11) Written informed conscent

Key exclusion criteria

1) Forbidden case to use S-1 and Trastuzumab
2) Infection or inflammatory case
3) Cardiovascular disease (congestive heart failure, Myocardial infarction, Ischemic heart disease, vulver disease)
4) Severe complicated case such as ileus, interstitial pneumonia, uncontrolled DM, liver cirrhosis etc.
5) Severe ascites and/or pleural effusion
6) Multiple bone metastasis
7) Clinical suspicion or previous history of metastasis to brain or meninges
8) Active digestive bleeding required repeat blood transfusion
9) severe diarrhea (4 times over /day)
10) Difficulty to join the trial due to
psychosis or psychotic symptoms or
central nervous system damage
11) Complicated other active cancer
12) patient who want to be pregnant and /or pregnant woman
13) Intend to make pregnant
14) 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	Takashi Fujimura

Organization

Kanazawa University Hospital

Division name

Gastroenterological Surgery

Zip code

Address

13-1 Takara-machi, Kanazawa

TEL

076-265-2362

Email

tphuji@staff.kanazawa-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Sachio Fushida

Organization

Kanazawa University Hospital

Division name

Gastroenterological Surgery

Zip code

Address

13-1 Takara-machi, Kanazawa

TEL

076-265-2362

Homepage URL

Email

fushida@staff.kanazawa-u.ac.jp

Institute

Digestive Desease Support Organization

Institute

Department

Personal name

Organization

Digestive Desease Support Organization

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

Date of disclosure of the study information

2011

Year

11

Month

22

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

Terminated

Date of protocol fixation

2011

Year

11

Month

02

Day

Date of IRB

Anticipated trial start date

2011

Year

12

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

11

Month

21

Day

Last modified on

2014

Year

11

Month

23

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007990