UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008623 |
|---|---|
| Receipt number | R000010128 |
| Scientific Title | Exploratory study of Paclitaxel+Trastuzumab therapy for advanced or recurrent gastric cancer with HER2 positive. |
| Date of disclosure of the study information | 2012/08/06 |
| Last modified on | 2017/07/31 14:05:51 |
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Basic information
Public title
Exploratory study of Paclitaxel+Trastuzumab therapy for advanced or recurrent gastric cancer with HER2 positive.
Acronym
Exploratory study of Paclitaxel+Trastuzumab therapy for advanced or recurrent gastric cancer with HER2 positive.
Scientific Title
Exploratory study of Paclitaxel+Trastuzumab therapy for advanced or recurrent gastric cancer with HER2 positive.
Scientific Title:Acronym
Exploratory study of Paclitaxel+Trastuzumab therapy for advanced or recurrent gastric cancer with HER2 positive.
Region
| Japan |
Condition
Condition
advanced or recurrent HER2-positive gastric cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Evaluation of the tolerability of PAC+Trastuzumab in HER2-positive advanced or recurrence gastric cancer patients. [Step1]
Evaluation of the tolerability and efficacy of PAC+Trastuzumab for Circulating Tumor Cells(CTC)from the patients with HER2-positive advanced or recurrence gastric cancer.
Evaluate of correlation between CTC numbers, CTC surface marker and PAC+trastuzumab treatment.
[Step2]
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
Safety
ORR:overall response rate
Progression free survival rate
Key secondary outcomes
Safety
PFS: progression free survival
OS: overall survival
TTP: Time to treatment failure
Prediction of effects based on the number of CTCs and PAC+T therapy
Prediction of effects based on markers on CTCs and PAC+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
Trastuzumab : 8 mg/kg(i.v.) for the initial dosing and 6 mg/kg for subsequent administration.
Trastuzumab administration will be repeated every 3 weeks.
Paclitaxel : 80 mg/m2 administered weekly on days 1, 8, and, 15 of 4-week period.
(Paclitaxel administration will be continued with 3 weekly infusions and 1 week of rest.)
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) Histological confirmation of gastric cancer (included with CTC) .
2) History of chemotherapy must be contain 5-fluoropyrimidine
3) Case with Measurable lesion.
4) HER2 positive (IHC 3+ or IHC 2+ /FISH +)
5) Age: 20 years or older
6) performance status (PS): 0 - 2. Eastern Cooperative Oncology Group (ECOG)
7) Adequate organ function as follows:
Neutrophils>=1500/mm3
Hemoglobin>=9.0 g/dl
Platelets>=100,000/mm3
Total bilirubin>=upper limit of normal (ULN)*1.5
AST and ALT <= upper limit of normal (ULN)*2.5
(<=ULN*5 in case of liver metastasis)
8) LVEF of >= 50% on echocardiography
9) Written informed consent.
Key exclusion criteria
1) Patient with a previous history of serious drug hypersensitivity. .
2) Patient with infectious diseases associated with a fever of 38.0 degrees C or higher
3) Patient with serious complications (interstitial pneumonia or pulmonary fibrosis, difficult-to-control diabetes, renal failure, hepatic failure, and so on)
4) Patient who has heart disease(CHF, old MI, IHD, arrhythmia, and a valvular disease of the heart)
5) Poorly-controlled hypertension
6) Patient with synchronous double cancer or metachronous double cancer with a disease-free interval of less than five years(In-situ cancer, gastric cancer, mucosal cancer, differentiated adenocarcinoma, and skin cancer judged to be cured by treatment are not considered to be active double cancers.)
7) Women of child-bearing potential (intention), pregnant or lactating women
8) Men desiring to have children
9) Patient judged by the investigator(s) to be inappropriate study participants for any other reason
Target sample size
36
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
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 08 | Month | 16 | 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
| 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=R000010128
