UMIN-CTR Clinical Trial

Basic information
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
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 unresecrable measurable advanced gastric cancer.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase II

Assessment
Primary outcomes	Response rate(RR)
Key secondary outcomes	Safety Progression-free survival(PFS) Overall survival(OS) 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 : 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

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 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

Research contact person
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

Public contact
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

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

Funding Source
Organization	Taiho Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
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

Other administrative information
Date of disclosure of the study information	2011 Year 06 Month 10 Day

Related information
URL releasing protocol	https://www.nature.com/articles/bjc201418
Publication of results	Published

Result
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

Progress
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
Other related information

Management information
Registered date	2011 Year 06 Month 07 Day
Last modified on	2022 Year 11 Month 06 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006758