UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008622 |
|---|---|
| Receipt number | 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 14:04:32 |
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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
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
satoshi.matsusaka@jfcr.or.jp
Sponsor or person
Institute
The Cancer Institute Hospital of JFCR
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010075
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