UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Exploratory study of Paclitaxel+Trastuzumab therapy for advanced or recurrent gastric cancer with HER2 positive.
Title of the study (Brief title)	Exploratory study of Paclitaxel+Trastuzumab therapy for advanced or recurrent gastric cancer with HER2 positive.
Region	Japan

Condition
Condition	advanced or recurrent HER2-positive gastric cancer
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	Evaluation of the tolerability of PAC+Trastuzumab in HER2-positive advanced or recurrence gastric cancer patients. [Step1] Evaluation of the tolerability and efficacy of PAC+Trastuzumab for Circulating Tumor Cells(CTC)from the patients with HER2-positive advanced or recurrence gastric cancer. Evaluate of correlation between CTC numbers, CTC surface marker and PAC+trastuzumab treatment. [Step2]
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase I,II

Assessment
Primary outcomes	Safety ORR:overall response rate Progression free survival rate
Key secondary outcomes	Safety PFS: progression free survival OS: overall survival TTP: Time to treatment failure Prediction of effects based on the number of CTCs and PAC+T therapy Prediction of effects based on markers on CTCs and PAC+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	Trastuzumab : 8 mg/kg(i.v.) for the initial dosing and 6 mg/kg for subsequent administration. Trastuzumab administration will be repeated every 3 weeks. Paclitaxel : 80 mg/m2 administered weekly on days 1, 8, and, 15 of 4-week period. (Paclitaxel administration will be continued with 3 weekly infusions and 1 week of rest.)
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) Histological confirmation of gastric cancer (included with CTC) . 2) History of chemotherapy must be contain 5-fluoropyrimidine 3) Case with Measurable lesion. 4) HER2 positive (IHC 3+ or IHC 2+ /FISH +) 5) Age: 20 years or older 6) performance status (PS): 0 - 2. Eastern Cooperative Oncology Group (ECOG) 7) Adequate organ function as follows: Neutrophils>=1500/mm3 Hemoglobin>=9.0 g/dl Platelets>=100,000/mm3 Total bilirubin>=upper limit of normal (ULN)*1.5 AST and ALT <= upper limit of normal (ULN)*2.5 (<=ULN*5 in case of liver metastasis) 8) LVEF of >= 50% on echocardiography 9) Written informed consent.
Key exclusion criteria	1) Patient with a previous history of serious drug hypersensitivity. . 2) Patient with infectious diseases associated with a fever of 38.0 degrees C or higher 3) Patient with serious complications (interstitial pneumonia or pulmonary fibrosis, difficult-to-control diabetes, renal failure, hepatic failure, and so on) 4) Patient who has heart disease(CHF, old MI, IHD, arrhythmia, and a valvular disease of the heart) 5) Poorly-controlled hypertension 6) Patient with synchronous double cancer or metachronous double cancer with a disease-free interval of less than five years(In-situ cancer, gastric cancer, mucosal cancer, differentiated adenocarcinoma, and skin cancer judged to be cured by treatment are not considered to be active double cancers.) 7) Women of child-bearing potential (intention), pregnant or lactating women 8) Men desiring to have children 9) Patient judged by the investigator(s) to be inappropriate study participants for any other reason
Target sample size	36

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	Enrolling by invitation
Date of protocol fixation	2011 Year 08 Month 01 Day
Anticipated trial start date	2011 Year 08 Month 16 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	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=R000010128