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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000017793
Receipt No. R000020613
Scientific Title Prospective observational study of resectability, safety, and efficacy for adjuvant surgery against initially unresectable pancreatic cancer responding to anti-cancer treatment
Date of disclosure of the study information 2015/06/04
Last modified on 2018/06/06

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Basic information
Public title Prospective observational study of resectability, safety, and efficacy for adjuvant surgery against initially unresectable pancreatic cancer responding to anti-cancer treatment
Acronym Prep-04
Scientific Title Prospective observational study of resectability, safety, and efficacy for adjuvant surgery against initially unresectable pancreatic cancer responding to anti-cancer treatment
Scientific Title:Acronym Prep-04
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the resectability, safety, and efficacy of adjuvant surgery for initially unresectable pancreatic cancer responding to anti-cancer treatment
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Resection rate
Key secondary outcomes Mortality, Morbidity, Survival, Recurrence, Tumor marker kinetics

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 1. Initially diagnosed as unresectable pancreatic cancer
2. Anti-cancer treatment (chemotherapy and/or radiotherapy etc) over 3 months before surgery
3. Obtained disease control by anti-cancer treatment
4. Planned surgery with informed consent
5. Tolerable for curative surgery
6. Written informed consent for the study
Key exclusion criteria 1. Under 20 year old at entry
2. Initially resectable
3. Anti-cancer treatment within 3 months before surgery
4. Disease progression at entry
5. Not planned surgery
6. Intolerable for curative surgery
7. Recurrent pancreatic cancer
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Michiaki Unno
Organization Tohoku University
Division name Surgery
Zip code
Address 1-1 Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan
TEL 022-717-7205
Email m_unno@surg1.med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Fuyuhiko Motoi
Organization Tohoku University
Division name Surgery
Zip code
Address 1-1 Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan
TEL 022-717-7205
Homepage URL http://www.surg1.med.tohoku.ac.jp/society/index.html
Email fmotoi@surg1.med.tohoku.ac.jp

Sponsor
Institute Study Group of Preoperative therapy for Pancreatic Cancer (Prep)
Institute
Department

Funding Source
Organization Study Group of Preoperative therapy for Pancreatic Cancer (Prep)
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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 06 Month 04 Day

Related information
URL releasing protocol http://www.surg.med.tohoku.ac.jp/surg1/society/prep04_siken.html
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 No longer recruiting
Date of protocol fixation
2015 Year 02 Month 04 Day
Date of IRB
Anticipated trial start date
2015 Year 06 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Initially unresectable pancreatic cancer has dismal prognosis with median 8 to 15 months for locally advanced or with median 8 to 12 months for metastatic disease even after chemotherapy or chemoradiotherapy. Despite improvement of recent treatment, long-term survival is rarely obtained. Project study of JHPBS-01 revealed that adjuvant surgery improved overall survival for initially unresectable pancreatic cancer treated over 6 months. Some other reports also showed the prolonged survival by adjuvant surgery, however, the indication, resectability, safety, and efficacy of adjuvant surgery was not fully elucidated.
This study is prospective observation for adjuvant surgery against initially unresectable pancreatic cancer responding to anti-cancer treatment to evaluate the resectability, safety, and efficacy by enrollment before surgery.

Management information
Registered date
2015 Year 06 Month 03 Day
Last modified on
2018 Year 06 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020613

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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