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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000010113
Receipt No. R000011776
Scientific Title A phase II clinical trial of neoadjyvant chemoradiation therapy using Gemcitabine combined with IMRT for borderline resectable pancreatic cancer
Date of disclosure of the study information 2013/03/01
Last modified on 2013/02/25

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Basic information
Public title A phase II clinical trial of neoadjyvant chemoradiation therapy using Gemcitabine combined with IMRT for borderline resectable pancreatic cancer
Acronym Neoadjuvant chemoradiation therapy for locally advanced pancreatic cancer
Scientific Title A phase II clinical trial of neoadjyvant chemoradiation therapy using Gemcitabine combined with IMRT for borderline resectable pancreatic cancer
Scientific Title:Acronym Neoadjuvant chemoradiation therapy for locally advanced pancreatic cancer
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the efficacy and safety of neoadjuvant chemoradiation therapy using Gemcitabine combined with IMRT for borderline resectable pancreatic cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes Histological curative resection rate
(R0 Ratio)
Key secondary outcomes pathological responce rate,
progression free survival, over all survival, incident of adverse event, mortality

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 To investigate the frequency of histological curative resection following chemoradiation using Gemcitabine combined with IMRT for borderline resectable pancreatic cancer
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.Patients with Histo-cytologically confirmed pancreatic cancer
2.Patients with radiologically defined patentially borderline resectable pancreatic cancer
3.Patients with Performance status of 0/1
4.Patients who have not undergone chemo and/or radiotherapyPatients with no metastatic disease confirmed by staging laparoscopy
5.Patiants who can oral intake
6.Patients with normal ECG findings
7.Patients with sustained organ function
8.Patients who received informed consent
Key exclusion criteria 1) Patients with lung fibrosis or interstitional pneumonia
2) Patients who can not underwent radiation therapy because of past radiation therapy
3) Severe co-morbid diseases
4) Intractable pleural and pericardical effusion, or ascites
5) Patients with other active cancers
6)Pregnancy or insufficient contraception
7) severe mental illness
8) Patients seems inadequate for this study by investigator(s)
Target sample size 37

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kyoichi Takaori
Organization Graduate School of Medicine and Faculty of Medicine KyotoUniversity
Division name Hepato-pancreato-biliary Surgery and Transplantation
Zip code
Address 54 Kawaharacho, Shogoin, Sakyo-ku Kyoto,
TEL 075-751-4323
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masaki Mizumoto
Organization Graduate School of Medicine and Faculty of Medicine KyotoUniversity
Division name Hepato-pancreato-biliary Surgery and Transplantation
Zip code
Address 54 Kawaharacho, Shogoin, Sakyo-ku Kyoto,
TEL 075-751-4323
Homepage URL
Email mizumoto@kuhp.kyoto-u.ac.jp

Sponsor
Institute Hepato-pamcreato-biliary Surgery and Transplantation,
Graduate School of Medicine and Faculty of Medicine KyotoUniversity
Institute
Department

Funding Source
Organization Hepato-pamcreato-biliary Surgery and Transplantation,
Graduate School of Medicine and Faculty of Medicine KyotoUniversity
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 京都大学医学部付属病院

Other administrative information
Date of disclosure of the study information
2013 Year 03 Month 01 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 Preinitiation
Date of protocol fixation
2013 Year 01 Month 24 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 01 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
2013 Year 02 Month 25 Day
Last modified on
2013 Year 02 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011776

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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