UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Phase II study of capecitabine plus cisplatin (plus trastuzumab) for previously untreated advanced gastric cancer.
Title of the study (Brief title)	XP+trastuzumab for advanced gastric cancer
Region	Japan

Condition
Condition	untreated advanced gastric cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of the safty and efficacy of capecitabine plus cisplatin (plus trastuzumab) for previously untreated advanced gastric cancer.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	PFS: Progression Free Survival
Key secondary outcomes	ORR: Overall Response Rate DCR: Disease Control Rate OS: Overall Survival The safty and efficacy of the biomarker; TP/DPD, HR, ER, PgR status

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	A group(HER2 negative):XP(CDDP 80mg/m2 d1 and Capecitabine 2000 mg/m2 d1-15 q3w) B group(HER2 positive):XP+HER(CDDP 80mg/m2 d1 and Capecitabine 2000 mg/m2 d1-15 and Trastuzumab 8 or 6 mg/kg q3w)
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) Non-curative resected or recurrent gastric cancer histologically proven adenocarcinoma (included EGJ cancer) (2) Written informed conscent to recieve this chemotherapy (3) More than 20 years old (4) Eastern Cooperative Oncology Groupe (ECOG) performance status of 0-2 (5) Life expectancy mor than 12 weeks (6) Presence of a measureable lesion for evaluation according to RECIST 1.1 (7) Adequate organ function as follows: 1. WBC count 4,000-12,000/mm3 2. Platelet count more than 100,000/mm3 3. Hemoglobin more than 8.0 g/dl 4. Serum bilirubin level less than 1.5 mg/dl 5.Ast and ALT less than 100IU/l 6. Alp within twice the normal upper limits 7. Serum creatinin level less than 1.5mf/dl (8) The patients can take food oraly (9) Without previous medication history such as radiation therapy, chemotherapy and immunotherapy (except adjuvant chenmotherapy) (10) Electrocardiogram was performed within 28 days
Key exclusion criteria	(1) Forbidden case to use capecitabine and/or cisplatin (2) Infection or inflammatory case (3) Severe heart disease (4) Severe complicated case such as ileus, interstitial pneumonia, uncontrolled DM, liver cirrhosis etc (5) a lot of ascites (6) many bone metastasis (7) brain metastasis (8) repeated gastrointestinal bleeding (9) severe psychological disease (10) complicated other active cancer (11) pregnant or intended to be pregnant (12) intend to make pregnant (13) others
Target sample size	53

Research contact person
Name of lead principal investigator	Toshihiro
Organization	Kawasaki Medical University
Division name	Digestive surgery
Address	577 Matsushima, Kurashiki, Okayama
TEL	086-462-1111
Email

Public contact
Name of contact person	Hideo Matsumoto
Organization	Kawasaki Medical University
Division name	Digestive surgery
Address	577 Matsushima, Kurashiki, Okayama
TEL	086-462-1111
Homepage URL
Email	h-matsu@med.kawasaki-m.ac.jp

Sponsor
Institute	Department of Digestive surgery, Kawasaki Medical University
Institute
Department

Funding Source
Organization	non
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	川崎医科大学付属病院

Other administrative information
Date of disclosure of the study information	2011 Year 08 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2011 Year 07 Month 10 Day
Anticipated trial start date	2011 Year 08 Month 01 Day
Last follow-up date	2014 Year 09 Month 01 Day
Date of closure to data entry	2014 Year 09 Month 01 Day
Date trial data considered complete	2014 Year 09 Month 01 Day
Date analysis concluded	2014 Year 09 Month 01 Day

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information	Primary endpoint: PFS Secondary endpoints: Overall responce rate, Disease control rate, Overall survival, biomarker( TP/DPD, ER, PGR, HER2)

Management information
Registered date	2011 Year 07 Month 19 Day
Last modified on	2017 Year 08 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000007036