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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000014789
Receipt No. R000017195
Scientific Title A prospective study to explore the relationship between SPARC expression and efficacy of nab-paclitaxel as second-line chemotherapy for advanced gastric cancer (SYNAPSE study)
Date of disclosure of the study information 2014/08/08
Last modified on 2017/08/09

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Basic information
Public title A prospective study to explore the relationship between SPARC expression and efficacy of nab-paclitaxel as second-line chemotherapy for advanced gastric cancer (SYNAPSE study)
Acronym A prospective study to explore the relationship between SPARC expression and efficacy of nab-paclitaxel as second-line chemotherapy for advanced gastric cancer (SYNAPSE study)
Scientific Title A prospective study to explore the relationship between SPARC expression and efficacy of nab-paclitaxel as second-line chemotherapy for advanced gastric cancer (SYNAPSE study)
Scientific Title:Acronym A prospective study to explore the relationship between SPARC expression and efficacy of nab-paclitaxel as second-line chemotherapy for advanced gastric cancer (SYNAPSE study)
Region
Japan

Condition
Condition Gastric cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the correlation between the expression of SPARC and the efficacy of nab-paclitaxel as second-line chemotherapy for metastatic or recurrent gastric cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Overall Survival according to SPARC expression
Key secondary outcomes Progression Free Survival
Time to Treatment Failure
Response Rate
Disease Control Rate
Dose Intensity
Adverse Event
Clinicopathological Characteristics of SPARC expression

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 nab-paclitaxel
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) Histlogically confirmed gastric adenocarcinoma
2) Unresectable or recurrent gastric cancer
3) No previous chemotherapy for other malignancies
4) Prior chemotherapy consisted of fluoropyrimidine for unresectable or reccurent gastric cancer
5) No past history of treatment related taxan
6) Age : 20 years old and more
7) ECOG Performance Status 0-2
8) Liffe expectancy : 90 days and more
9) Adequate organ function as evidenced by the follow laboratory studies within 28 days prior to enrollment
a)Neutrophil conunt : 1,500 /mm3 or above
b)Platet count : 100,000 /mm3 or above
c) Hemoglobin : 8.0 g/dL or above
d) Total bilirubin : 1.5 mg/dL or less
e) AST(GOT) : 100 IU/L or less (200 IU/L or less in patients with liver metastasis)
f) ALT(GPT) : 100 IU/L or less (200 IU/L or less in patients with liver metastasis)
g) Serum creatinine : 1.5 mg/dL or less
10) Tumor tissue can be used for this study
11) Written informed consent
Key exclusion criteria 1) Multiple primary cancers with disease-free period less than 5-years, except carcinoma in situ or intra mucosal disease cured by local therapy
2) Past history of severe hypersensitivity to drug
3) Active incection
4) Fever more than 38 degree
5) Central nervous system metastasis or carcinomatous meningitis
6) Massive cardiac effusion, pleural effusion or ascites
7) Peripheral sensory neuropathy : grade 2 or above (CTCAE v4.0)
8) Chronic daily treatment with oral or intravenous corticosteroids
9) Unstable angina or past history of myocardinal infraction in 6 months
10) Evidence of any other serious disease ; renal failure, hepatic failure, interstinal pneumonitis or lung fibrosis
11) Pregnant, lactating female, female of childbearing potential or male without contracepcion intention
12) Psychiatric disease that is inapprocpriate for entry into this study
13) Any patients judged by the investigator to be unfit to participate in the study
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kentaro Yamashita
Organization Sapporo Medical University
Division name Department of Gastroenterology, Rheumatology and Clinical Immunology
Zip code
Address South 1 West 16, Chuo-ku, Sapporo, 060-8543, Japan
TEL +81-11-611-2111
Email ykentaro@sapmed.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kei Onodera
Organization Sapporo Medical University
Division name Department of Gastroenterology, Rheumatology and Clinical Immunology
Zip code
Address South 1 West 16, Chuo-ku, Sapporo, 060-8543, Japan
TEL +81-11-611-2111
Homepage URL
Email konodera@sapmed.ac.jp

Sponsor
Institute Department of Gastroenterology, Rheumatology and Clinical Immunology, Sapporo Medical University
Institute
Department

Funding Source
Organization Department of Gastroenterology, Rheumatology and Clinical Immunology, Sapporo Medical University
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
2014 Year 08 Month 08 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
2014 Year 06 Month 06 Day
Date of IRB
Anticipated trial start date
2014 Year 08 Month 08 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
2014 Year 08 Month 07 Day
Last modified on
2017 Year 08 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017195

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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