UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024091 |
|---|---|
| Receipt number | 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 | 2023/03/24 18:46:49 |
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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 | Yasushi |
| Middle name | |
| Last name | Ichikawa |
Organization
Yokohama City University Hospital
Division name
Department of Oncology
Zip code
236-0004
Address
3-9, Fuku-ura, Kanazawa-ku, Yokohama
TEL
045-787-2623
norikoba@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Noritoshi |
| Middle name | |
| Last name | Kobayashi |
Organization
Yokohama City University Hospital
Division name
Department of Oncology
Zip code
236-0004
Address
3-9, Fuku-ura, Kanazawa-ku, Yokohama
TEL
045-787-2623
Homepage URL
norikoba@yokohama-cu.ac.jp
Sponsor or person
Institute
yokohama city university hospital oncology division
Institute
Department
Personal name
Funding Source
Organization
yokohama city university hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yokohama City University Hospital
Address
3-9, Fuku-ura, Kanazawa-ku, Yokohama
Tel
+81457872623
norikoba@yokohama-cu.ac.jp
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
undisclosed
Publication of results
Unpublished
Result
URL related to results and publications
undisclosed
Number of participants that the trial has enrolled
35
Results
undisclosed
Results date posted
| 2022 | Year | 02 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
undisclosed
Participant flow
undisclosed
Adverse events
undisclosed
Outcome measures
undisclosed
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 05 | Month | 09 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 19 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 31 | Day |
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
| 2023 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027730
