UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029501 |
|---|---|
| Receipt number | R000033702 |
| Scientific Title | Feasibility study of surgical resection after chemoradiotherapy for locally advanced unresectable pancreatic cancer with major arterial invasion |
| Date of disclosure of the study information | 2017/10/16 |
| Last modified on | 2022/04/14 17:57:32 |
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Basic information
Public title
Feasibility study of surgical resection after chemoradiotherapy for locally advanced unresectable pancreatic cancer with major arterial invasion
Acronym
Feasibility study of surgical resection after chemoradiotherapy for locally advanced unresectable pancreatic cancer with major arterial invasion
Scientific Title
Feasibility study of surgical resection after chemoradiotherapy for locally advanced unresectable pancreatic cancer with major arterial invasion
Scientific Title:Acronym
Feasibility study of surgical resection after chemoradiotherapy for locally advanced unresectable pancreatic cancer with major arterial invasion
Region
| Japan |
Condition
Condition
oancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We investigate the feasibility of surgical resection after chemoradiotherapy for locally advanced unresectable pancreatic cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Treatment completion ratio
Key secondary outcomes
safety(mobidity, mortality)
residual tumor
Histological treatment effect
Overall survival
Relapse-free survival
Recurrence form
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Cases in which pancreatic cancer has been confirmed from image findings (As far as possible, histology examination / cytodiagnosis is performed to confirm that it is an adenocarcinoma)
2) Patients with locally advanced unresectable pancreatic cancer without distant metastasis
3) Patients whose age is under 80 at the time of consent acquisition
4) Patients with ECOG Performance Status (PS) of 0 or 1
5) Patients whose main organ function is adequately maintained
6) After receiving sufficient explanation for the participation of this study, patients who gained written consent by the patient's free will with sufficient understanding
Key exclusion criteria
1) Patients with distant metastasis
2) Patients with obvious pulmonary fibrosis or interstitial pneumonia (confirmed by chest X-ray)
3) Patients with severe infection complications
4) Patients with difficult heart failure despite treatment, angina pectoris, arrhythmias and myocardial infarction within 6 months after onset
5) diabetic patients who are difficult to control
6) Pregnant women, patients who are lactating or are likely or willing to become pregnant
7) Patients with severe drug allergy
8) Patients with active double cancer
9) Cases showing diarrhea (watery stool)
10) Pleural effusion requiring treatment, ascites retention cases requiring treatment, cases with image pericardial effusion
11) Patients with other serious complications
12) Others, examination responsibility (shared) Patients judged unsuitable by the doctor as subjects
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Amano |
| Middle name | |
| Last name | Ryosuke |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Surgical Oncology
Zip code
5458585
Address
1-4-3 Asahimachi, Abeno-ku, Osaka
TEL
06-6645-3838
ramano@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | Amano |
| Middle name | |
| Last name | Ryosuke |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Surgical Oncology
Zip code
5458585
Address
1-4-3 Asahimachi, Abeno-ku, Osaka
TEL
06-6645-3838
Homepage URL
http://www.med.osaka-cu.ac.jp/surgical-oncology/
ramano@med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University Graduate School of Medicine
Department of Surgical Oncology
Institute
Department
Personal name
Funding Source
Organization
non
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 City University Graduate School of Medicine
Address
1-4-3 Asahimachi, Abeno-ku, Osaka
Tel
06-6645-3447
shinki@med.osaka-cu.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
大阪市立大学医学部附属病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | Month | 16 | Day |
Related information
URL releasing protocol
http://www.med.osaka-cu.ac.jp/surgical-oncology/
Publication of results
Unpublished
Result
URL related to results and publications
http://www.med.osaka-cu.ac.jp/surgical-oncology/
Number of participants that the trial has enrolled
64
Results
Surgery cases MST is 23.4 months
Non-surgical cases MST is 10.8 months
Results date posted
| 2021 | Year | 04 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
22 female and 42 male
mean age 65.19 years
NCCN classification BR:27 UR37
Participant flow
63 of 64 completed NACRT
Pancreatic resection was performed in 43 cases
Adverse events
2 of 43 deaths related to surgery
Outcome measures
Surgery cases MST is 23.4 months
Non-surgical cases MST is 10.8 months
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2014 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 09 | Month | 29 | Day |
Anticipated trial start date
| 2014 | Year | 09 | Month | 29 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 07 | Month | 31 | Day |
Other
Other related information
Sixty-four patients were enrolled in the study.
Currently, monitoring registered cases
Management information
Registered date
| 2017 | Year | 10 | Month | 10 | Day |
Last modified on
| 2022 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033702
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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