UMIN-CTR Clinical Trial

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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