UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022938 |
|---|---|
| Receipt number | R000026436 |
| Scientific Title | The study on the antitumor effect of medication for underlying diseases of the patients with unresectable pancreatic carcinoma who undergo standard chemotherapy. |
| Date of disclosure of the study information | 2016/06/29 |
| Last modified on | 2025/07/08 20:27:39 |
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Basic information
Public title
The study on the antitumor effect of medication for underlying diseases of the patients with unresectable pancreatic carcinoma who undergo standard chemotherapy.
Acronym
The study on the antitumor effect of concomitant drug with chemotherapeutic agent for the patients with unresectable pancreatic carcinoma.
Scientific Title
The study on the antitumor effect of medication for underlying diseases of the patients with unresectable pancreatic carcinoma who undergo standard chemotherapy.
Scientific Title:Acronym
The study on the antitumor effect of concomitant drug with chemotherapeutic agent for the patients with unresectable pancreatic carcinoma.
Region
| Japan |
Condition
Condition
pancreatic carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to reveal the antitumor effect of medication for underlying diseases of the patients with unresectable pancreatic carcinoma who undergo standard chemotherapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Progression free survival
Key secondary outcomes
Response rate
Disease control rate
Overall survival
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
The patients with stage 4b pancreatic carcinoma
Key exclusion criteria
None
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hitoshi |
| Middle name | |
| Last name | Yoshiji |
Organization
Nara Medical University
Division name
Department of Gastroenterology, Endocrinology and Metabolism
Zip code
634-8521
Address
840 Shijo-cho, Kashihara, Nara
TEL
0744-22-3051
yoshijih@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Mitoro |
Organization
Nara Medical University
Division name
Department of Gastroenterology, Endocrinology and Metabolism
Zip code
634-8521
Address
840 Shijo-cho, Kashihara, Nara
TEL
0744-22-3051
Homepage URL
mitoroak@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
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
Clinical Research Center Nara Medical University
Address
840 Shijo-cho, Kashihara, Nara
Tel
0744-22-3051
icats@naramed-u.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 | 06 | Month | 29 | Day |
Related information
URL releasing protocol
none
Publication of results
Unpublished
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
15
Results
The study was terminated when the number of participants who gave written consent was not reached.
Results date posted
| 2025 | Year | 07 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with inoperable pancreatic cancer with distant metastasis
Participant flow
observational study
Adverse events
none
Outcome measures
Progression free survival
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2016 | Year | 06 | Month | 20 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 13 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 29 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
we survey the medication for underlying diseases of the patients with stage 4b pancreatic carcinoma. We perform chemotherapy and observe the antitumor effect and prognosis of the patients. We estimate the influence of concomitant drugs on the antitumor effect of the chemotherapy and prognosis of subjects.
Management information
Registered date
| 2016 | Year | 06 | Month | 29 | Day |
Last modified on
| 2025 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026436
