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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000037142
Receipt No. 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

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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
Email 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/
Email hakita@gesurg.med.osaka-u.ac.jp

Sponsor
Institute Osaka University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042301

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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