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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000017169
Receipt No. R000019917
Scientific Title Evaluation of adjuvant pancreatectomy for initially unresectable pancreatic cancer with preoperatively undetectable distant metastasis after chemotherapy
Date of disclosure of the study information 2015/04/20
Last modified on 2015/11/18

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Basic information
Public title Evaluation of adjuvant pancreatectomy for initially unresectable pancreatic cancer with preoperatively undetectable distant metastasis after chemotherapy
Acronym Evaluation of adjuvant pancreatectomy for initially unresectable pancreatic cancer with preoperatively undetectable distant metastasis after chemotherapy
Scientific Title Evaluation of adjuvant pancreatectomy for initially unresectable pancreatic cancer with preoperatively undetectable distant metastasis after chemotherapy
Scientific Title:Acronym Evaluation of adjuvant pancreatectomy for initially unresectable pancreatic cancer with preoperatively undetectable distant metastasis after chemotherapy
Region
Japan

Condition
Condition pancretatic cancer
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluation of adjuvant pancreatectomy for initially unresectable pancreatic cancer with distant micro metastasis after chemotherapy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes survival rate at 2-year.
Key secondary outcomes overall survival
recurrent free survival at 1-year
R0 resection rate
pattern of recurrence
tumor marker

Base
Study type

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 Treatment
Type of intervention
Maneuver
Interventions/Control_1 Pancreatectomy for the patients with disease control with chemotherapy for more than 3 months
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 (1) histolycally proven invasive pancreatic ductal adenocarcinoma
(2) the number of intraabdominal distant metastasis is 5 or less, and all of them were removed for histological diagnosis at laparotomy
(3)no distant metastasis with preoperative imaging (CT, MRI, FDG-PET-CT)
(4) R01 resection is possible for primary cancer
(5) with tolerable health to operation
(6) no prior therapy for pancreas cancer except for metastatectomy at 1st laparotomy
(7) not enrolled in other study with primary endpoint of resection or survival
(8) no other active cancer
(9) expect survival time is 6-month and more
(10) with consent in a writing form
(11) 20 years old or older with judgement
Key exclusion criteria (1) not diagnosed as invasive pancreatic ductal adenocarcinoma
(2) the number of distant metastasis is 6 or more
(3) with detectable distant metastasis by preoperative image
(4) R2 resection is expected
(5) without tlerable health to operation
(6) recurrent pancreatic cancer
(7) enrolled in other study with primary endpoint of resection or survival
(8) with another active cancer
(9) with uncontrollable infection
(10) in pregnancy
(11) expected survival time is less than 6 months
(12) chemotherapy is difficult
(13) younger than 20 years old
(14) without judgement
Target sample size 75

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroki Hayashi
Organization Tohoku University
Division name Surgery
Zip code
Address Sendai
TEL 022-717-7205
Email hiroki@srurg1.med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroki Hayashi
Organization Tohoku University
Division name Surgery
Zip code
Address Sendai
TEL 922-717-7205
Homepage URL
Email hiroki@surg1.med.tohoku.ac.jp

Sponsor
Institute Department of surgery, Tohoku university school of medicine
Institute
Department

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
Address
Tel
Email

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
2015 Year 04 Month 20 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 Enrolling by invitation
Date of protocol fixation
2015 Year 03 Month 10 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 20 Day
Last follow-up date
2020 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 04 Month 18 Day
Last modified on
2015 Year 11 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019917

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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