UMIN-CTR Clinical Trial

Basic information
Public title	Combination treatment with TS-1+CDDP+Trastuzumab for unresectable HER 2 positive gastric cancer (A Phase II Study)
Acronym	GCSPH
Scientific Title	Combination treatment with TS-1+CDDP+Trastuzumab for unresectable HER 2 positive gastric cancer (A Phase II Study)
Scientific Title:Acronym	GCSPH
Region	Japan

Condition
Condition	Unresectable HER2 positive gastric cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Safety
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Antitumor efficacy
Key secondary outcomes	Progression-free survival (PFS) Overall survival (OS) Antitumor efficacy Adverse events

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	Chemotherapy with S-1(80mg/m2/day 14days), Cisplatin(20mg/m2/day day1,8), Trastuzumab(1st-8mg/kg 2nd-6mg/kg)
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. Gastric cancer confirmed by histology 2. Patients with unresectable or recurrent gastric cancer 3. HER2 positive confirmed by histology (IHC(immunohistochemistry) 3+, or IHC 2+ and FISH (fluorescence in situ hybridization) positive)) 4. Tumor lesion able to be measured 5. No prior radiotherapy, chemotherapy or hormone therapy 6. Performance Status (ECOG) 0-1 7. Age of 20 to 75 8. Patients with no peritoneal metastasis, intestinal obstruction and no acites 9. Sufficient oral intake 10. Adequate organ functions: WBC >=3500/mm3 and <=12000/mm3, neutrophils >=2000/mm3, platelets >=100,000/mm3, hemoglobin >=9.0g/dL, total bilirubin <=1.5mg/dL, AST(GOT)/ALT(GPT) within twice the normal upper limits creatinin within the normal limits creatinine clearance >=60mL/min. 11. Normal ECG and LVEF>=50% 12. Written informed consent.
Key exclusion criteria	1. patient who has drug allergy as past history 2. patient who needs flucytosine, phenytoin, and Warfarin 3. patient who has active infectious disease with fever over 38 degree 4. patient who has severe complication (interstitial pneumonia, DM, renal failure, liver failure under bad control) 5. watery diarrhea 6. Pleural effusion and acites 7. patient who has heart disease(CHF, old MI, IHD, arrhythmia, and a valvular disease of the heart) 8.Uncontrolable hypertention 9. patient who has active double cancer 10. patient who want to be pregnant and /or pregnant woman 11. man who want to have a child 12. patient who was judged to be unsuitable for this clinical trial
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hideaki Shimada
Organization	Toho University School of Medicine
Division name	Department of Surgery
Zip code
Address	6-11-1 Omori-Nishi, Ota-ku, Tokyo
TEL	03-3762-4151
Email	hideaki.shimada@med.toho-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Yoshinori Kikuchi
Organization	Toho University School of Medicine
Division name	Department of Internal Medicine
Zip code
Address	6-11-1 Omori-nishi Otaku Tokyo
TEL	03-3762-4151
Homepage URL
Email	y-kikuchi@med.toho-u.ac.jp

Sponsor
Institute	Toho University
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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 07 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
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

Progress
Recruitment status	Terminated
Date of protocol fixation	2011 Year 03 Month 23 Day
Date of IRB	2011 Year 07 Month 01 Day
Anticipated trial start date	2011 Year 07 Month 01 Day
Last follow-up date	2013 Year 08 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 29 Day
Last modified on	2021 Year 08 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006580