UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Exploratory study of Xeloda+CDDP(XP)+Trastuzumab therapy for advanced gastric cancer with HER2 positive CTCs
Title of the study (Brief title)	Exploratory study of Xeloda+CDDP(XP)+Trastuzumab therapy for advanced gastric cancer with HER2 positive CTCs
Region	Japan

Condition
Condition	Advanced gastric cancer patients with HER2 over expression CTCs whose primary lesion is HER2 negative or of unknown HER2 status
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety and efficacy of Xeloda+CDDP(XP)+Trastuzumab therapy for advanced gastric cancer patients with HER2 positive CTCs whose primary lesion is HER2 negative or unmeasurableHER2 status. To evaluate relationship between the number of CTCs/makers on CTCs and XP+H therapy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	ORR: overall response rate Progression free survival rate
Key secondary outcomes	Safety PFS: progression free survival OS: overall survival Prediction of effects based on the number of CTCs and XP+T therapy Prediction of effects based on markers on CTCs and XP+T therapy

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	XP(capecitabine+cisplatin)+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	Not applicable
Gender	Male and Female
Key inclusion criteria	(1) Written informed consent. (2) 20 years old or more when received informed consent. (3) Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0 - 2. (4) Life expectancy estimated 3 months, and more. (5) Histological confirmation of gastric cancer. (6) Confirmed HER2 positive CTCs. (7) Advanced gastric cancer patients with HER2 positive CTCs whose primary lesion is HER2 negative or unmeasurableHER2 status. With measurable lesion. (8) Patients with metastatic gastric cancer who had received no previous therapy. Patients with recurrent colorectal cancer Who have not been administered any therapy to the recurrent site. (relapse morth than 6 months after adj-therapy) (9) Vital organ functions (listed below) are preserved within 14 days prior to entry. 1.Neutrophils>=1500/mm3 2. Platelets>=100,000/mm3 3. Hemoglobin>=9.0 g/dl 4. Total bilirubin>=upper limit of normal (ULN)*1.5 5. AST and ALT <= upper limit of normal (ULN)*2.5 (<=ULN*5 in case of liver metastasis) 6. Serum creatinine <= upper limit of normal (ULN) *1.5 7. Creatinine clearance >= 60 ml/min
Key exclusion criteria	(1) Baseline left ventricular ejection fraction (LVEF) => 50% measured by echocardiography or MUGA scan (2)CNS metastases or brain cancer confirmed by imaging. (3) Patients who meet any of the following criteria will be excluded from the study. 1. Patient with a previous history of congestive heart failure 2. Unstable angina requiring med 3.Confirmed transmural myocardial infarction by ECG 4.Uncontrolled hypertension(SAP>180mmHg or DBP>=100mmHg) 5. Severe heart valve disease 6. Hi-risk uncontrolled arrhythmias (4) History of active double cancer within 5 year. (without healed cutaneous basal cell carcinomas and carcinoma in situ of the cervix, or digestive system cancer verified cure by endoscopic mucosal resection) (5) Severe pulmonary disease (Interstitial pneumonitis or pulmonary fibrosis) (6) History of the organ transplantation to need an immunosuppressive drug (7) Not appropriate for the study at the physician's assessment
Target sample size	30

Research contact person
Name of lead principal investigator	Satoshi Matsusaka
Organization	The Cancer Institute Hospital of JFCR
Division name	Gastroenterology
Address	135-8550, 3-8-31 Ariake Koto-ku Tokyo
TEL	03-3520-0111
Email	satoshi.matsusaka@jfcr.or.jp

Public contact
Name of contact person	Satoshi Matsusaka
Organization	The Cancer Institute Hospital of JFCR
Division name	Gastroenterology
Address	135-8550, 3-8-31 Ariake Koto-ku Tokyo
TEL	03-3520-0111
Homepage URL
Email	satoshi.matsusaka@jfcr.or.jp

Sponsor
Institute	The Cancer Institute Hospital of JFCR
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)

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	2012 Year 08 Month 06 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2011 Year 04 Month 13 Day
Anticipated trial start date	2011 Year 08 Month 11 Day
Last follow-up date	2013 Year 08 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2012 Year 08 Month 05 Day
Last modified on	2017 Year 07 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010075