UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037142 |
|---|---|
| Receipt number | R000042301 |
| Scientific Title | The combination of CA19-9 normalization and metabolic tumor volume change predicts long-term survival for resectable and borderline resectable pancreatic cancer patients receiving preoperative chemoradiotherapy; the result of multicenter trial. |
| Date of disclosure of the study information | 2019/06/24 |
| Last modified on | 2019/06/23 14:10:50 |
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Basic information
Public title
The combination of CA19-9 normalization and metabolic tumor volume change predicts long-term survival for resectable and borderline resectable pancreatic cancer patients receiving preoperative chemoradiotherapy; the result of multicenter trial.
Acronym
The combination of CA19-9 and PET for the assessment of PC patients with NACRT
Scientific Title
The combination of CA19-9 normalization and metabolic tumor volume change predicts long-term survival for resectable and borderline resectable pancreatic cancer patients receiving preoperative chemoradiotherapy; the result of multicenter trial.
Scientific Title:Acronym
The combination of CA19-9 and PET for the assessment of PC patients with NACRT
Region
| Japan |
Condition
Condition
Pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In this study, we examined what FDG-PET and serum CA19-9 represent to predict the response to neoadjuvant therapy and the surgical outcome in pancreatic cancer patients.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
Disease free survival
Pathological effect
Pathological staging
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Pnacreatic cancer patients who underwent radical surgery after neoadjuvant chemoradiotherapy.
Key exclusion criteria
1, Patients under 20 years old
2, In cases that CA19-9 and FDG-PET was not performed both before and after chemoradiotherapy.
3, In cases that the value of CA19-9 was within normal limits before the initiation of neoadjuvant chemotherapy.
4, In cases that the value of SUV-max before neoadjuvant chemoradiotherapy was under 2.0.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Akita |
| Middle name | |
| Last name | Hirofumi |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Gastoroenterological Surgery
Zip code
5650871
Address
2-2, Yamadaoka, Suita City, Osaka, Japan
TEL
0668793251
hakita@gesurg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Akita |
| Middle name | |
| Last name | Hirofumi |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Gastoroenterological Surgery
Zip code
5650871
Address
2-2, Yamadaoka, Suita City, Osaka, Japan
TEL
0668793251
Homepage URL
https://www2.med.osaka-u.ac.jp/gesurg/
hakita@gesurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
Nothing
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
Osaka University Graduate School of Medicine
Address
2-2, Yamadaoka, Suita City, Osaka, Japan
Tel
0668793251
hakita@gesurg.med.osaka-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
| 2019 | Year | 06 | Month | 24 | 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
Preinitiation
Date of protocol fixation
| 2019 | Year | 06 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
not particular
Management information
Registered date
| 2019 | Year | 06 | Month | 23 | Day |
Last modified on
| 2019 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042301
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
