UMIN-CTR Clinical Trial

Public title

Phase ll trial of TS-1 + CDDP + Trastuzumab(SPT)-3 weekly schedule in HER2-positive advanced gastric cancer(HERBIS-1) (OGSG 1101)

Acronym

HER2-Based Strategy in Gastric Cancer(HERBIS-1) (OGSG 1101)

Scientific Title

Phase ll trial of TS-1 + CDDP + Trastuzumab(SPT)-3 weekly schedule in HER2-positive advanced gastric cancer(HERBIS-1) (OGSG 1101)

Scientific Title:Acronym

HER2-Based Strategy in Gastric Cancer(HERBIS-1) (OGSG 1101)

Region

Japan

Condition

Advanced Gastric Cancer

Classification by specialty

Gastroenterology

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the safety and efficacy of TS-1 + cisplatin + Trastuzumab 3-weekly schedule regimen for initially unresecrable measurable advanced gastric cancer.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase II

Primary outcomes

Response rate(RR)

Key secondary outcomes

Safety
Progression-free survival(PFS)
Overall survival(OS)
Time to treatment failure(TTF)

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

Drug : TS-1, cisplatin, and trastuzumab
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

Age-lower limit

20

years-old

<=

Age-upper limit

75

years-old

>=

Gender

Male and Female

Key inclusion criteria

1. Histologically confirmed unresectable or recurrent gastric adenocarcinoma including adenocarcinoma of the gastro-esophageal junction.
2. Patients who have measurable region defined by RECIST version 1.1 within 21 days before enrollment.
3. Patients who have HER2-positive cancer confirmed with IHC and/or FISH (IHC 3+ or IHC 2+ and FISH positive).
4. Age 20-75
5. Performance status (ECOG scale) 0
or 1.
6. No prior chemotherapy or radiotherapy for gastric cancer.
7. No massive ascites or massive pleural effusion retention.
8. Patients without brain metastasis.
9. 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
10. Patients with left ventricular ejection fraction of at least 50% on MUGA (Multi Gated Acquisition Scan) or echocardiography done within 21 days before enrollment.
11. No abnormal findings requiring treatment in the electrocardiogram within 21 days before enrollment.
12. Patients able to take orally.
13. Life expectancy of greater than 3 months.
14. 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 resting dyspnea
8. Patients with fresh bleeding from gastric cancer and/or the digestive tract
9. Patients with diarrhea (4 or more times per day or watery diarrhea).
10.Second primary malignancy (except adequately treated basal cell carcinoma treated more than 5 years ago without recurrence)
11. Patients who are received systemic continuous administration of flucytosine, phenytoin, or warfarin.
12. Patients who are received systemic administration of corticosteroid.
13. Any patients judged by the investigator to be unfit to participate in the study.

Target sample size

50

Name of lead principal investigator

1st name
Middle name
Last name	Hiroya Takiuchi , Yukihiro Kurokawa

Organization

Osaka Medical College
Osaka University Graduate School of Medicen

Division name

Cancer Chemotherapy Center, Department of Gastroenterological Surgery

Zip code

Address

2-7 Daigaku-cho, Takatsuki, Osaka, 569-8181, Japan 2-2-E2 Yamadaoka, Suita, Osaka, 565-0871, Japan

TEL

06-6879-3251

Email

ykurokawa@gesurg.med.osaka-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Yuinori Kurokawa

Organization

Osaka University Graduate School of Medicen

Division name

Department of Gastroenterological Surgery

Zip code

Address

2-2-E2 Yamadaoka, Suita, Osaka, 565-0871, Japan

TEL

06-6879-3251

Homepage URL

Email

ykurokawa@gesurg.med.osaka-u.ac.jp

Institute

Osaka Gastrointestinal cancer chemotherapy Study Group (OGSG)

Institute

Department

Personal name

Organization

Taiho Pharmaceutical Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

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

06

Month

10

Day

URL releasing protocol

https://www.nature.com/articles/bjc201418

Publication of results

Published

URL related to results and publications

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3950868/

Number of participants that the trial has enrolled

56

Results

A total of 56 patients were enrolled. In the full analysis set of 53 patients, the confirmed RR was 68% (95% confidence interval (CI)=54-80%), and the disease control rate was 94% (95% CI=84-99%). Median OS, PFS, and TTF were estimated as 16.0, 7.8, and 5.7 months, respectively.

Results date posted

2020

Year

01

Month

05

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

2014

Year

05

Month

04

Day

Baseline Characteristics

patients with human epidermal growth factor receptor type 2 (HER2)-positive AGC

Participant flow

Patients with HER2-positive AGC received S-1 (80-120 mg per day) orally on days 1-14, cisplatin (60mg/m2) intravenously on day 1, and trastuzumab (course 1, 8mg/kg ; course 2 onward, 6mg/kg) intravenously on day 1 of a 21-day cycle.

Adverse events

Major grade 3 or 4 adverse events included neutropaenia (36%), anorexia (23%), and anaemia (15%).
Creatinine was elevated in24 of 53 patients (45%). Heart failure did not occur inany patients.

Outcome measures

The primary end point was response rate (RR); secondary end points included overall survival (OS), progression-free survival (PFS), time to treatment failure (TTF), and adverse events.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2011

Year

05

Month

14

Day

Date of IRB

2011

Year

07

Month

12

Day

Anticipated trial start date

2011

Year

07

Month

21

Day

Last follow-up date

2014

Year

05

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2011

Year

06

Month

07

Day

Last modified on

2022

Year

11

Month

06

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006758