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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000008622
Receipt No. R000010075
Scientific Title Exploratory study of Xeloda+CDDP(XP)+Trastuzumab therapy for advanced gastric cancer with HER2 positive CTCs
Date of disclosure of the study information 2012/08/06
Last modified on 2017/07/31

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Basic information
Public title Exploratory study of Xeloda+CDDP(XP)+Trastuzumab therapy
for advanced gastric cancer with HER2 positive CTCs
Acronym Exploratory study of Xeloda+CDDP(XP)+Trastuzumab therapy
for advanced gastric cancer with HER2 positive CTCs
Scientific Title Exploratory study of Xeloda+CDDP(XP)+Trastuzumab therapy
for advanced gastric cancer with HER2 positive CTCs
Scientific Title:Acronym 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
1st name
Middle name
Last name Satoshi Matsusaka
Organization The Cancer Institute Hospital of JFCR
Division name Gastroenterology
Zip code
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
1st name
Middle name
Last name Satoshi Matsusaka
Organization The Cancer Institute Hospital of JFCR
Division name Gastroenterology
Zip code
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)

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
2012 Year 08 Month 06 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 No longer recruiting
Date of protocol fixation
2011 Year 04 Month 13 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000010075

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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