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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000005998
Receipt No. R000007036
Scientific Title A Phase II study of capecitabine plus cisplatin (plus trastuzumab) for previously untreated advanced gastric cancer.
Date of disclosure of the study information 2011/08/01
Last modified on 2017/08/01

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Basic information
Public title A Phase II study of capecitabine plus cisplatin (plus trastuzumab)
for previously untreated advanced gastric cancer.
Acronym XP+trastuzumab for advanced gastric cancer
Scientific Title A Phase II study of capecitabine plus cisplatin (plus trastuzumab)
for previously untreated advanced gastric cancer.
Scientific Title:Acronym 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
1st name
Middle name
Last name Toshihiro
Organization Kawasaki Medical University
Division name Digestive surgery
Zip code
Address 577 Matsushima, Kurashiki, Okayama
TEL 086-462-1111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hideo Matsumoto
Organization Kawasaki Medical University
Division name Digestive surgery
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2011 Year 07 Month 10 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000007036

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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