UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020809 |
|---|---|
| Receipt number | R000024023 |
| Scientific Title | Increased tumour ADC value during chemotherapy predicts improved survival in unresectable pancreatic cancer |
| Date of disclosure of the study information | 2016/01/31 |
| Last modified on | 2016/01/31 03:00:53 |
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Basic information
Public title
Increased tumour ADC value during chemotherapy predicts improved survival in unresectable pancreatic cancer
Acronym
ADC value during chemotherapy in pancreatic cancer
Scientific Title
Increased tumour ADC value during chemotherapy predicts improved survival in unresectable pancreatic cancer
Scientific Title:Acronym
ADC value during chemotherapy in pancreatic cancer
Region
| Japan |
Condition
Condition
unresectable pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether changes to the apparent diffusion coefficient of primary tumour in the early period after starting chemotherapy can predict progression- free survival or overall survival in patients with unresectable pancreatic adenocarcinoma.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between ADC change and survival
Key secondary outcomes
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
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
MRI is performed 4 weeks after starting of chemotherapy
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
(i) no prior treatment; (ii) maximum diameter of pancreas tumour >1 cm; (iii) Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 2; and (iv) adequate bone marrow, kidney and liver function.
Key exclusion criteria
the presence of a contraindication for magnetic resonance imaging
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideyuki Nishiofuku |
Organization
Nara Medical University
Division name
Radiology
Zip code
Address
840 Shijo-cho Kashihara-city, Nara
TEL
0744-29-8900
hmn@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideyuki Nishiofuku |
Organization
Nara Medical University
Division name
Radiology
Zip code
Address
840 Shijo-cho Kashihara-city, Nara
TEL
0744-29-8900
Homepage URL
hmn@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
Radiology, Nara Medical University
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
Address
Tel
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 | 01 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2008 | Year | 01 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 02 | Month | 27 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 01 | Month | 31 | Day |
Last modified on
| 2016 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024023
