UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A feasibility study of docetaxel + cisplatin + capecitabine (DCX) therapy for unresectable advanced gastric cancer
Title of the study (Brief title)	A feasibility study of docetaxel + cisplatin + capecitabine (DCX) therapy for unresectable advanced gastric cancer
Region	Japan

Condition
Condition	Gastric cancer
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate safety and tolerability of docetaxel + cisplatin + capecitabine (DCX) therapy for unresectable advanced gastric cancer
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Adverse events
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	Capecitabine 2000mg/m2/day days 1-14 Cisplatin 60mg/m2 day1 Docetaxel 30mg/m2 or 40mg/m2 day1 every 3 weeks
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 adenocarcinoma. HER2 IHC- or IHC1+, or IHC2+/FISH- 2) Stage IV 3) ECOG PS 0-1 4) No previous chemothrapy or radiation therapy 5) Laboratory data 1.WBC>=3,000/mimcrol 2.Neutrophil>=1,500/microl 3.Hemoglobin>=8.0 g/dL 4.Platelet>=100,000/microl 5.Total bilirubin<=1.5 mg/dL 6.AST(GOT)<=ULNx2.5(<=ULNx5 if presence of liver metastasis) 7.ALT(GPT)<=ULNx2.5(<=ULNx5 if presence of liver metastasis) 8.Serum creatinine<=1.3 mg/dL 9.Creatinine clearance>=60 mL/min 10.Ejection fraction on echo cardiogram>=50%
Key exclusion criteria	1) HER2 IHC 3+, or IHC 2 and FISH+ 2) Uncontrolled diabetes 3) Uncontrolled hypertension 4) Unstable angina pectoris, or a history of myocardial infarction within six months 5) Chronic lung disease: interstitial pneumonia, pulmonary fibrosis, or severe emphysema 6) Synchronous cancers 7) Systemic infection requiring treatment 8) Fever above 38 degree Celsius 9) A possibility of pregnancy or during pregnancy, or lactating women 10) Psychosis or psychotic symptoms 11) Continuous systemic administration of steroids (oral or intravenous)
Target sample size	6

Research contact person
Name of lead principal investigator	Osamu Maeda
Organization	Nagoya University Hospital
Division name	Department of Gastroenterology
Address	65 Tsurumai-cho Showa-ku Nagoya
TEL	052-741-2111
Email	maeda-o@med.nagoya-u.ac.jp

Public contact
Name of contact person	Osamu Maeda
Organization	Nagoya University Hospital
Division name	Department of Gastroenterology
Address	65 Tsurumai-cho Showa-ku Nagoya
TEL	052-741-2111
Homepage URL
Email	maeda-o@med.nagoya-u.ac.jp

Sponsor
Institute	Department of Gastroenterology, Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Department of Gastroenterology, Nagoya University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information	2011 Year 07 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 07 Month 14 Day
Anticipated trial start date	2011 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2011 Year 07 Month 20 Day
Last modified on	2018 Year 01 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000007110