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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024091
Receipt No. R000027730
Scientific Title Phase II study of capecitabine and temozolomide (CAPTEM)in patients with unresectable neuroendocrien tumor
Date of disclosure of the study information 2016/09/17
Last modified on 2016/09/17

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Basic information
Public title Phase II study of capecitabine and temozolomide (CAPTEM)in patients with unresectable neuroendocrien tumor
Acronym CAPTEM therapy for unresectable neuroendocrine tumor
Scientific Title Phase II study of capecitabine and temozolomide (CAPTEM)in patients with unresectable neuroendocrien tumor
Scientific Title:Acronym CAPTEM therapy for unresectable neuroendocrine tumor
Region
Japan

Condition
Condition gastroenteropancreatic neuroendocrine tumor
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine Hematology and clinical oncology
Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Efficacy of the CAPTEM therapy for the patients with unresectable gastroenteropancreatic neuroendocrine tumors
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Overall response rate
Key secondary outcomes Time to treatment failure
Progression-free survival
Overall survival

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 Chemotherapy by Capecitabine and Temozolomide
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
76 years-old >
Gender Male and Female
Key inclusion criteria unresectable gastroenteropancreatic neuroeondocrine tumor (WHO 2010 Grade 1,2,3) and primary unknown NET
Key exclusion criteria Hb < 8.0g/dl
WBC <3000
Neutrocyte <1500
Plt <100000
severe liver or renal disease
T-bil> 3ULN
Alb <3.0g/dl
AST> 5 X ULN
ALT> 5 X ULN
brain metastasis
severe bone metastasis
uncontrolable DM
severe heart disease
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ichikawa Yasushi
Organization Yokohama City University Hospital
Division name Department of Oncology
Zip code
Address 3-9, Fuku-ura, Kanazawa-ku, Yokohama
TEL 045-787-2623
Email norikoba@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Noritoshi Kobayashi
Organization Yokohama City University Hospital
Division name Department of Oncology
Zip code
Address 3-9, Fuku-ura, Kanazawa-ku, Yokohama
TEL 045-787-2623
Homepage URL
Email norikoba@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University
Institute
Department

Funding Source
Organization Self funding
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
2016 Year 09 Month 17 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 Open public recruiting
Date of protocol fixation
2016 Year 05 Month 09 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 19 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
2016 Year 09 Month 17 Day
Last modified on
2016 Year 09 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027730

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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