UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007941
Receipt number R000009278
Scientific Title Phase ll trial of TS-1 + CDDP + Trastuzumab (SPT) - 3 weekly schedule in HER2-positive advanced gastric cancer without measurable metastatic lesion (HERBIS-1B) (OGSG 1202)
Date of disclosure of the study information 2012/05/14
Last modified on 2020/01/22 22:19:14

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Basic information

Public title

Phase ll trial of TS-1 + CDDP + Trastuzumab (SPT) - 3 weekly schedule in HER2-positive advanced gastric cancer without measurable metastatic lesion
(HERBIS-1B) (OGSG 1202)

Acronym

HER2-Based Strategy in Gastric Cancer (HERBIS-1B) (OGSG 1202)

Scientific Title

Phase ll trial of TS-1 + CDDP + Trastuzumab (SPT) - 3 weekly schedule in HER2-positive advanced gastric cancer without measurable metastatic lesion
(HERBIS-1B) (OGSG 1202)

Scientific Title:Acronym

HER2-Based Strategy in Gastric Cancer (HERBIS-1B) (OGSG 1202)

Region

Japan


Condition

Condition

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 initially unresectable advanced gastric cancer without measurable lesion

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase II


Assessment

Primary outcomes

Overall Survival(OS)

Key secondary outcomes

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


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, cisplatin, and trastuzumab
TS-1: 80 mg/m2/day po on Days 1-14
Cisplatin: 60 mg/m2 iv on Day 1
Trastuzumab: 8 mg/kg iv on Day 1 (first course), and 6 mg/kg iv on Day 1 (from second courses)

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

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 no measurable legion 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 /mm3 <=12,000 /mm3
b) Absolute neutrophil count: >=2,000 / mm3
c) Platelets: >=100,000 / mm3
d) Hemoglobin: >=9.0 g/dL
e) AST (SGOT)/ALT (SGPT) < 100 IU/L
f) Total bilirubin <1.5 mg/dL
g) Serum creatine >=1.2 mg/dL
h) Creatinine clearance: >=60 mL/min
i) 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. Patient 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

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yukinori Kurokawa

Organization

Osaka University Graduate School of Medicine

Division name

Department of Gastroenterological Surgery

Zip code


Address

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

TEL

06-6879-3251

Email

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


Public contact

Name of contact person

1st name
Middle name
Last name Yukinori Kurokawa

Organization

Osaka University Graduate School of Medicine

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


Sponsor or person

Institute

Osaka Gastrointestinal cancer chemotherapy Study Group (OGSG)

Institute

Department

Personal name



Funding Source

Organization

Osaka Clinical Study Supporting Organization

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


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

東大阪市立総合病院(大阪府)、大崎市民病院(宮城県)、箕面市立病院(大阪府)、堺市立総合医療センター(大阪府)、大阪大学(大阪府)、八尾市立病院(大阪府)、昭和大学横浜市北部病院(神奈川県)、大阪警察病院(大阪府)、大阪医療センター(大阪府)、関西労災病院(兵庫県)


Other administrative information

Date of disclosure of the study information

2012 Year 05 Month 14 Day


Related information

URL releasing protocol

http://ar.iiarjournals.org/content/39/2/1059

Publication of results

Published


Result

URL related to results and publications

http://ar.iiarjournals.org/content/39/2/1059

Number of participants that the trial has enrolled

15

Results

Fifteen patients were enrolled. The median overall survival was 14.4 months. The 1- and 3-year overall survival rates were 66.7 % and 26.7 %, respectively.

Results date posted

2020 Year 01 Month 05 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2019 Year 01 Month 15 Day

Baseline Characteristics

Patients with HER2-positive gastric cancer without measurable lesions

Participant flow

Patients with HER2-positive gastric cancer without measurable lesions received cisplatin plus trastuzumab intravenously on day 1 and oral S-1 on days 1-14 of a 21-day cycle.

Adverse events

Major grade 3-4 adverse events included neutropenia (47%), anemia (40%), diarrhea (20%), nausea (20%), and anorexia (20%).

Outcome measures

The primary end-point was overall survival.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2012 Year 04 Month 23 Day

Date of IRB

2012 Year 07 Month 24 Day

Anticipated trial start date

2013 Year 02 Month 22 Day

Last follow-up date

2018 Year 03 Month 16 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2018 Year 05 Month 28 Day


Other

Other related information



Management information

Registered date

2012 Year 05 Month 13 Day

Last modified on

2020 Year 01 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009278


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name