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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000009718
Receipt No. R000009464
Scientific Title Evaluation of Safety and Efficacy about Resection of Pancreatic Cancer with Preoperatively Undetectable Intraabdominal Distant Metastasis
Date of disclosure of the study information 2013/01/08
Last modified on 2014/02/07

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Basic information
Public title Evaluation of Safety and Efficacy about Resection of Pancreatic Cancer with Preoperatively Undetectable Intraabdominal Distant Metastasis
Acronym Evaluation of Safety and Efficacy about Resection of Pancreatic Cancer with Preoperatively Undetectable Intraabdominal Distant Metastasis
Scientific Title Evaluation of Safety and Efficacy about Resection of Pancreatic Cancer with Preoperatively Undetectable Intraabdominal Distant Metastasis
Scientific Title:Acronym Evaluation of Safety and Efficacy about Resection of Pancreatic Cancer with Preoperatively Undetectable Intraabdominal Distant Metastasis
Region
Japan

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

Objectives
Narrative objectives1 Safety about the resection of pancreatic cancer with intraabdominal distant metastasis
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Perioperative safety
Key secondary outcomes - Relapse free survival,
- Type of recurrence,
- Time course of tumor marker,
- The rate of administration of postoperarive adjuvant chemotherapy,
- Survival time after recurrence
- Over all survival


Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Resection of preoperatively undetectable intraabodominal distant metastasis and primary cancer, if R0 resection is possible.
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) no distant metastasis with preoperative imaging (CT, MRI, FDG-PET-CT)
(3) R0 resection is possible for primary cancer
(4) with tolerable health to operation
(5) no prior therapy for pancreas cancer
(6) not enrolled in other study with primary endpoint of resection or survival
(7) no other active cancer
(8) with consent in a writing form
(9) 20 years old or older
(10) with judgement
Key exclusion criteria (1) not diagnosed as invasive pancreatic ductal adenocarcinoma
(2) with distant metastasis
(3) R2 resection is expected
(4) without tlerable health to operation
(5) recurrent pancreatic cancer
(6) enrolled in other study with primary endpoint of resection or survival
(7) with another active cancer
(8) in pregnancy
(9) younger than 20 years old
(10) without judgement
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroki Hayashi
Organization Tohoku University Hospital
Division name Hepato-Biliary Pancreatic surgery
Zip code
Address Sendai
TEL 022-717-7205
Email hiroki@surg1.med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroki Hayashi
Organization Tohoku University Hospital
Division name Hepato-Biliary Pancreatic surgery
Zip code
Address 1-1 Seiryo-machi, Aoba-ku, Sendai
TEL 022-717-7205
Homepage URL
Email hiroki@surg1.med.tohoku.ac.jp

Sponsor
Institute Hepato-Biliary Pancreatic surgery, Tohoku University Hospital
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 東北大学病院(宮城県)

Other administrative information
Date of disclosure of the study information
2013 Year 01 Month 08 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
2012 Year 12 Month 22 Day
Date of IRB
Anticipated trial start date
2013 Year 01 Month 09 Day
Last follow-up date
2018 Year 01 Month 08 Day
Date of closure to data entry
2018 Year 01 Month 08 Day
Date trial data considered complete
2018 Year 01 Month 08 Day
Date analysis concluded
2018 Year 01 Month 08 Day

Other
Other related information

Management information
Registered date
2013 Year 01 Month 07 Day
Last modified on
2014 Year 02 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009464

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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