UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Trastuzumab incombination with S-1/CDDP of HER2-positive advanced gastric cancer: a phase II trial.
Title of the study (Brief title)	Trastuzumab incombination with S-1/CDDP of HER2-positive advanced gastric cancer.
Region	Japan

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

Objectives
Narrative objectives1	Efficacy
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	one year survival rate
Key secondary outcomes

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	S-1/CDDP+Trastuzumab
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1. case which was diagnosed as gastric cacner by histopathologically. 2. Stage IV gastric cancer 3. HER2 positive (IHC 3+ or IHC 2+ and FISH positive) 4. age 20-80 Y 5. ECOG PS:0-2 6. case which has lesions to be evaluated 7. patient who is possible of ingestion 8. initial treatment case (patient who had adjuvant chemotherapy by TS-1 more than 24 weeks ago) 9. patient who is expected to be survival more than 3 months 10. LVEF>50% by UCG 11. WBC:3,000 / mm3-12,000 / mm3 Neutro:>1,500/mm3 Plt:>100,000/mm3 Hb:>9.0 g/dl AST(GOT),ALT(GPT):>100 IU / l T-Bil:<2.0mg / dl C.Cr:>60ml / min (Cockcroft- Gault) 12. patient who was taken IC by document.
Key exclusion criteria	1. patient who has drug allergy as past history 2. case of administration contraindication 3. patient who needs flucytosine, phenytoin, and Warfarin 4. patient who has active infectious disease with fever over 38 degree 5. patient who has severe complication (intestinal palsy, ileus, interstitial pneumonia, DM, renal failure, liver failure under bad control) 6. patient who has heart disease(CHF, old MI, IHD, arrhythmia, and a valvular disease of the heart) 7. patient who has metastatic brain tumor with symptoms 8. watery diarrhea 9. severe ascites and/or pleural effusion 10. patient who has active double cancer 11. patient who want to be pregnant and /or pregnant woman 12. man who want to have a child 13. patient who was not judged to be suitable for this clinical trial
Target sample size	30

Research contact person
Name of lead principal investigator	Hiromi Kataoka
Organization	Nagoya City University Hospital
Division name	Dept. of Gastroenterology, Div. of Endoscopy
Address	1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, Japan
TEL	052-853-8211
Email	hkataoka@med.nagoya-cu.ac.jp

Public contact
Name of contact person	Hiromi Kataoka
Organization	Nagoya City University Hospital
Division name	Dept. of Gastroenterology
Address	1 Kawasumi, Mizuho-cho, Mizuho-ku,Nagoya,Japan
TEL	052-853-8211
Homepage URL
Email	hkataoka@med.nagoya-cu.ac.jp

Sponsor
Institute	Dept. of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Nagoya Daini Red Cross Hospital, Nagoya City East Medical Center, West Medical Center, Bisai Hospital, NTT West Tokai Hospital, Toyokawa City Hospital, Asahi Rousai Hospital, Tajimi Hospital,Gamagoori Municipal Hospital
Name of secondary funｄer(s)

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	名古屋市立大学病院（愛知県），名古屋第二赤十字病院（愛知県），名古屋市立東部医療センター（愛知県），名古屋市立西部医療センター（愛知県），愛知県厚生農業協同組合連合会尾西病院（愛知県），NTT西日本東海病院（愛知県），豊川市民病院（愛知県），旭労災病院（愛知県），岐阜県立多治見病院（岐阜県），社会保険中京病院（愛知県），蒲郡市民病院（愛知県）

Other administrative information
Date of disclosure of the study information	2011 Year 06 Month 17 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 06 Month 06 Day
Anticipated trial start date	2011 Year 06 Month 01 Day
Last follow-up date	2016 Year 06 Month 30 Day
Date of closure to data entry	2016 Year 08 Month 31 Day
Date trial data considered complete	2016 Year 08 Month 31 Day
Date analysis concluded	2016 Year 08 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information	Kataoka H, Mori Y, Shimura T, Nishie H, Natsume M, Mochizuki H, Hirata Y, Sobue S, Mizushima T, Sano H, Mizuno Y, Nakamura M, Hirano A, Tsuchida K, Adachi K, Seno K, Kitagawa M, Kawai T, Joh T. A phase II prospective study of the trastuzumab combined with 5-weekly S-1 and CDDP therapy for HER2-positive advanced gastric cancer. Cancer Chemother Pharmacol. 2016 May;77(5):957-62.

Management information
Registered date	2011 Year 06 Month 16 Day
Last modified on	2016 Year 10 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000006849