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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020366
Receipt No. R000023523
Scientific Title Considerations of recurrence prevention efficacy of gemcitabine for patients with resected pancreatic cancer
Date of disclosure of the study information 2015/12/27
Last modified on 2015/12/29

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Basic information
Public title Considerations of recurrence prevention efficacy of gemcitabine for patients with resected pancreatic cancer
Acronym Considerations of recurrence prevention efficacy of gemcitabine for patients with resected pancreatic cancer
Scientific Title Considerations of recurrence prevention efficacy of gemcitabine for patients with resected pancreatic cancer
Scientific Title:Acronym Considerations of recurrence prevention efficacy of gemcitabine for patients with resected pancreatic cancer
Region
Japan

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

Objectives
Narrative objectives1 The aim of this study is to evaluate the efficacy of recurrence prevention using gemcitabine for patients with resected pancreatic cancer.
Basic objectives2 Others
Basic objectives -Others Outside comparative study to 'The development of a novel dual-targeting peptide vaccine therapy in patients with resected pancreatic cancer' UMIN000007991
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes disease-free survival
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Gemcitabine will be administered intravenously at a fixed dose of 1000mg/m2 on days,1,8 and 15 for 24 weeks.
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) Invasive pancreatic ductal carcinoma histologically confirmed as papillary adenocarcinoma, tubular adenocarcinoma, poorly differentiated adenocarcinoma or adenosquamous carcinoma of the pancreas.
(2) Histologically confirmed R0 or R1 resected invasive pancreatic ductal carcinoma.
(3) No recurrence
(4) No Prior treatment for pancreatic cancer except surgical resection.
(5) Patients must be >=20 years old and <=80 years old at the time of consent.
(6) ECOG Performance Status must be 0 or 1.
(7) The following criteria must be satisfied in laboratory tests.
1) White blood cell count >=3,500/mm3
2) Neutrophil count >=2,000/mm3
3) Hemoglobin >= 9.0 g/dL
4) Platelet count >=100,000mm3
5) Total bilirubin <=2.0 mg/dL
6) AST <=150 IU/L
7) ALT <=150 IU/L
8) Serum Creatinine <=1.5 mg/dL

(8) No abnormal findings requiring treatment in the electrocardiogram within 21 days before enrollment.

(9) Patients must be enrolled more than 2 weeks elapsed from resection of pancreatic cancer, not to exceed 10 weeks.

(10) Patients must have signed the consent form.
Key exclusion criteria (1) Interstitial pneumonia or pulmonary fibrosis.
(2) Patients who require systemic administration of the following agents during the study treatment period.
1.Corticosteroid
2.Immunosuppresant, Immunostimulant
(3) Active infections.
(4) Severe complication (heart failure, renal failure, liver failure, bleeding from digestive ulcer, ileus,and uncontrolled diabetes)
(5) Pleural effusion, ascites fluid, or pericardial fluid in need of drainage.
(6) Active double cancer (include asynchronous double cancer with disease-free duration <=3 year) except carcinoma in situ or intramucosal cancer.
(7) Prior treatment of peptide derived from KIF20A, VEGFR-1and VEGFR-2.
(8) Prior cancer treatment except for pancreatic cancer (chemotherapy, hormone therapy, antibody therapy, radiation therapy, immunotherapy, and hyperthermia).
(9) Severe mental disorder.
(10) Sever drug-induced hypersensitivity
(11) Unhealed traumatic lesion, including traumatic fracture.
(12) History of myocardial infarction, severe unstable angina pectoris, CABG, congestive heart failure, cerebrovascular accident, pulmonary embolism, deep-vein thrombosis, or other severe thromboembolism within 12 months before administration of OCV-C01.
(13) Need continuous medication of antiplatelet drug except aspirin.
(14) Uncontrolled hypertension.
(15) Heart failure and arrhythmia that needs treatment.
(16) Aneurysms and varices with serious concern of bleeding.
(17) Current participation in other clinical trials.
(18) Patients or partners, who don't attempt to doing contraception during the study period (during the study period and until 180 days after the last administration day for male, or until 120 days after the last administration day for female.).
(19) Pregnant females or nursing mothers who can not stop lactation during the recruitment until 120 days after the last administration.
(20) The subject who was determined by investigator that being not adequate to participate in the trial.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroki Yamaue
Organization Wakayama Medical University
Division name Second Department of Surgery
Zip code
Address 811-1 Kimiidera Wakayama
TEL 073-441-0613
Email yamaue-h@wakayama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Motoki Miyazawa
Organization Wakayama Medical University
Division name Second Department of Surgery
Zip code
Address 811-1 Kimiidera Wakayama
TEL 073-441-0613
Homepage URL
Email mo-0702@wakayama-med.ac.jp

Sponsor
Institute Second Department of Surgery, Wakayama Medical University
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
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

Other administrative information
Date of disclosure of the study information
2015 Year 12 Month 27 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 Completed
Date of protocol fixation
2012 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 07 Month 01 Day
Last follow-up date
2014 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 12 Month 27 Day
Last modified on
2015 Year 12 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023523

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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