UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057588 |
|---|---|
| Receipt number | R000065802 |
| Scientific Title | Updated Analysis of Treatment Outcomes with Temozolomide Plus Capecitabine in Patients with Pancreatic Neuroendocrine Tumors in Japan |
| Date of disclosure of the study information | 2025/04/11 |
| Last modified on | 2025/04/11 16:20:38 |
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Basic information
Public title
Updated Analysis of Treatment Outcomes with Temozolomide Plus Capecitabine in Patients with Pancreatic Neuroendocrine Tumors in Japan
Acronym
JON2305-N
Scientific Title
Updated Analysis of Treatment Outcomes with Temozolomide Plus Capecitabine in Patients with Pancreatic Neuroendocrine Tumors in Japan
Scientific Title:Acronym
JON2305-N
Region
| Japan |
Condition
Condition
Pancreatic neuroendocrine tumors
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to clarify the real-world use of the combination therapy of temozolomide and capecitabine for pancreatic neuroendocrine tumors in Japan.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Objective response rate (RECIST version 1.1)
Key secondary outcomes
Disease control rate, progression-free survival, overall survival, adverse events, and serious adverse events (CTCAE version 5.0)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients with pancreatic neuroendocrine tumors* who received CAPTEM therapy at participating institutions.
*Pancreatic neuroendocrine tumors include NET (neuroendocrine tumor), NEC (neuroendocrine carcinoma), and MiNEN (mixed neuroendocrine-non-neuroendocrine neoplasm).
2)Patients who initiated the therapy between January 1, 2008, and December 31, 2023.
3)Patients enrolled in the Usage Survey 2018 (A Survey on the Use of Temozolomide plus Capecitabine Therapy for Pancreatic Neuroendocrine Tumors).
Key exclusion criteria
None
Target sample size
106
Research contact person
Name of lead principal investigator
| 1st name | Takuji |
| Middle name | |
| Last name | Okusaka |
Organization
National Cancer Center Hospital
Division name
Department of Hepatobiliary and Pancreatic Oncology
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan
TEL
03-3542-2511
tokusaka@ncc.go.jp
Public contact
Name of contact person
| 1st name | Kanae |
| Middle name | |
| Last name | Inoue |
Organization
National Cancer Center Hospital East
Division name
Department of Hepatobiliary and Pancreatic Oncology
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa-shi, Chiba, Japan
TEL
04-7133-1111
Homepage URL
kaninoue@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Japan
Institute
Department
Personal name
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
Institutional Review Board, National Cancer Center Japan
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan
Tel
03-3542-2511
irst@ml.res.ncc.go.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
JON2305-N
Org. issuing International ID_1
Japan Oncology Network in Hepatobiliary and Pancreas
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 11 | 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
| 2024 | Year | 05 | Month | 28 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 03 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 28 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2025 | Year | 04 | Month | 11 | Day |
Last modified on
| 2025 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065802
