UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000007941
Receipt No. 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 (Ver. 20)

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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
Institute Osaka Gastrointestinal cancer chemotherapy Study Group (OGSG)
Institute
Department

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009278