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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006590
Receipt No. R000007783
Scientific Title Capecitabine / Cisplatin / Trastuzumab for previously untreated HER2 positive advanced gastric cancer.-Phase II study-
Date of disclosure of the study information 2011/10/22
Last modified on 2013/01/23

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Basic information
Public title Capecitabine / Cisplatin / Trastuzumab for previously untreated HER2 positive advanced gastric cancer.-Phase II study-
Acronym XP+HER for previously untreated HER2 positive advanced gastric cancer.-Phase II study-
Scientific Title Capecitabine / Cisplatin / Trastuzumab for previously untreated HER2 positive advanced gastric cancer.-Phase II study-
Scientific Title:Acronym XP+HER for previously untreated HER2 positive advanced gastric cancer.-Phase II study-
Region
Japan

Condition
Condition untreated HER2 positive advanced gastric cancer
Classification by specialty
Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluation of the efficacy and safety of capecitabine plus cisplatin plus trastuzumab for previously untreated HER2 positive advanced gastric cancer.
Basic objectives2 Safety,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
Safety

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 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

Not applicable
Age-upper limit
70 years-old >
Gender Male and Female
Key inclusion criteria (1) Non-curative resected or recurrent gastric cancer histologically proven adenocarcinoma (included EGJ cancer)
(2) Positive HER2 status(IHC3+ or IHC2+/FISH+)
(3) Written informed conscent to receive this chemotherapy.
(4) Less than 70 years old.
(5) Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
(6) Life expectancy of at least 3 months after registration.
(7) Case which has lesions to be evaluated according to RECIST (Response Evaluation Criteria in Solid Tumors) guideline.
(8) Adequate organ function as follows:
1. WBC count 4,000-12,000/mm3
2. Neutrophils count more than 1,500/mm3
3. Platelet count more than 100,000/mm3
4. Hemoglobin more than 8.0 g/dl
5. Serum bilirubin level less than 1.5 mg/dl
6. Ast and ALT less than 100 IU/l
7. Serum creatinine level less than 1.2 mg/dl
8. Creatinine clearance more than 30mL/min
9. LVEF more than 50%
(9) Patient who is possible of ingestion.
(10) Without previous medication history such as radiation therapy, chemotherapy and endocrine therapy (except adjuvant chemotherapy exclude cisplatin).
(11) Electrocardiogram was performed within 28 days.
Key exclusion criteria (1) Forbidden case to use capecitabine, Cisplatin and Trastuzumab.
(2) R1 operation(histlogically positive PM, OM, LM, VM).
(3) Infection or inflammatory case.
(4) Severe heart disease.
(5) Severe complicated case such as ileus, interstitial pneumonia, uncontrolled DM, liver cirrhosis etc.
(6) Severe ascites and/or pleural effusion.
(7) Multiple bone metastasis.
(8) Clinical suspicion or previous history of metastasis to brain or meninges.
(9) Difficulty to join the trial due to
psychosis or psychotic symptoms or
central nervous system damage.
(10)Complicated other active cancer.
(11)patient who want to be pregnant and /or pregnant woman.
(12)Intend to make pregnant.
(13)Active hepatitis type HBs positive.
(14)Otherwise determined by investigators or site principal investigators to be unsuitable for participation in study.
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsuo Tokuka
Organization Shimane Prefectural Central Hospital
Division name Department of Surgery
Zip code
Address 4-1-1, Himehara, Izumo 693-8501, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Shimane Prefectural Central Hospital
Division name Department of Surgery
Zip code
Address 4-1-1, Himehara, Izumo 693-8501, Japan
TEL
Homepage URL
Email

Sponsor
Institute Herceptin Database of Shimane Prefecture
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)

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

Other administrative information
Date of disclosure of the study information
2011 Year 10 Month 22 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 Completed
Date of protocol fixation
2011 Year 08 Month 25 Day
Date of IRB
Anticipated trial start date
2011 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 10 Month 21 Day
Last modified on
2013 Year 01 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007783

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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