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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000004422
Receipt No. R000005282
Scientific Title Preoperative chemoradiation therapy combined with peptide vaccination for T3-pancreatic cancer: prospective phase I/II study
Date of disclosure of the study information 2010/10/20
Last modified on 2018/04/26

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Basic information
Public title Preoperative chemoradiation therapy combined with peptide vaccination for T3-pancreatic cancer: prospective phase I/II study
Acronym Preoperative multimodal treatment for pancreatic cancer
Scientific Title Preoperative chemoradiation therapy combined with peptide vaccination for T3-pancreatic cancer: prospective phase I/II study
Scientific Title:Acronym Preoperative multimodal treatment for pancreatic cancer
Region
Japan

Condition
Condition T3(UICC)-pancreatic cancer
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of preoperative chemoradiation therapy combined with peptide vaccination for resectable pancreatic cancer patient.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes Safety
Disease free survival
Key secondary outcomes Overall survival,
Histopathological and immunological response, pattern of recurrence

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Preoperative gemcitabine-based chemoradiation therapy with peptide vaccination
Interventions/Control_2 Preoperative gemcitabine-based chemoradiation therapy without peptide vaccination
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
85 years-old >
Gender Male and Female
Key inclusion criteria Resectable Pancreatic cancer ; T3 of UICC TNM classification of malignant tumours 7th edition). Histological or cytological confirmation as pancreatic adenocarcinoma
is required. No contraindication for gemcitabine-based chemoradiation therapy.
Key exclusion criteria Liver, renal dysfunction, severe coronary disease.
Unresectable pancreatic cancer, including borderline resectable cases.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hidenori Takahashi
Organization Osaka Medical Center for Cancer & Cardiovascular Diseases
Division name Department of Gastroenterological surgery
Zip code
Address 1-3-3, Nakamichi, Higashinari-ku, Osaka, 537-8511, Japan
TEL 06-6945-1181
Email takahasi-hi@mc.pref.osaka.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hidenori Takahashi
Organization Osaka Medical Center for Cancer & Cardiovascular Diseases
Division name Department of Gastroenterological surgery
Zip code
Address 1-3-3, Nakamichi, Higashinari-ku, Osaka, 537-8511, Japan
TEL 06-6972-1181
Homepage URL
Email takahasi-hi@mc.pref.osaka.jp

Sponsor
Institute Department of Gastroenterological Surgery, Osaka Medical Center for cancer & Cardiovascular Diseases
Institute
Department

Funding Source
Organization Osaka Medical Center for cancer & Cardiovascular Diseases
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Human Genome Center, Institute of Medical Science, University of Tokyo
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
2010 Year 10 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 No longer recruiting
Date of protocol fixation
2010 Year 04 Month 14 Day
Date of IRB
Anticipated trial start date
2010 Year 06 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
2010 Year 10 Month 20 Day
Last modified on
2018 Year 04 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005282

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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