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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005776
Receipt No. R000006825
Scientific Title Clinical study of autologous tumor lysate-pulsed dendritic cell therapy after resection of lung cancer
Date of disclosure of the study information 2011/06/14
Last modified on 2014/05/23

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Basic information
Public title Clinical study of autologous tumor lysate-pulsed dendritic cell therapy after resection of lung cancer
Acronym Clinical study of autologous tumor lysate-pulsed dendritic cell therapy after resection of lung cancer
Scientific Title Clinical study of autologous tumor lysate-pulsed dendritic cell therapy after resection of lung cancer
Scientific Title:Acronym Clinical study of autologous tumor lysate-pulsed dendritic cell therapy after resection of lung cancer
Region
Japan

Condition
Condition lung cancer
Classification by specialty
Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate safety and efficacy on combination therapy of autologous tumor lysate-pulsed dendritic cell vaccination and standard adjuvant chemotherapy after resection of lung cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Safety
Key secondary outcomes Immunological responses
Recurrence-free survival
Overall survival
Survival rate (3 and 5 years)
Response of tumor-related markers

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 Vaccine Maneuver
Interventions/Control_1 1)Tumor lysate-pulsed dendritic cells (biweekly, 6 times)
2)Standard adjuvant chemotherapy
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 Lung cancer patients who received resection of primary lesion:
(1)Performance Status is 0-1
(2)No serious abnormality in bone marrow, liver, and renal functions
(3)Whose life-expectancy is more than 3 months
Key exclusion criteria Patients who have:
(1)Pulmonary fibrosis or interstitial pneumonia, or history or predisposition of them
(2)Serious drug allergy
(3)Serious cardiac disease
(4)Active autoimmune disease
(5)Other cancers
(6)Active infections
(7)Positive for HIV or HTLV-1
(8)Other serious complications
(9)Pregnant or lactating
(10)Continuous systemic administration of steroids
(11)Any reason why, in the opinion of the investigator, the patient should not participate.
Target sample size 8

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kosei Yasumoto
Organization Seta Clinic Fukuoka
Division name Medical oncology
Zip code
Address Random square 5F, 6-18 Tenya-machi, Hakata-ku, Fukuoka, 812-0025, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Ibe
Organization Seta Clinic
Division name Clinical research center
Zip code
Address Kokoro to karada no genki plaza 8F, 3-6-5 Iidabashi, Chiyoda-ku, Tokyo, 102-0072, Japan
TEL 03-5215-0086
Homepage URL
Email scrc@j-immunother.com

Sponsor
Institute Seta Clinic Fukuoka
Institute
Department

Funding Source
Organization Medinet Co.,Ltd.
Organization
Division
Category of Funding Organization Profit 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 瀬田クリニック福岡(福岡県)

Other administrative information
Date of disclosure of the study information
2011 Year 06 Month 14 Day

Related information
URL releasing protocol
Publication of results Published

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
2011 Year 06 Month 10 Day
Date of IRB
Anticipated trial start date
2011 Year 06 Month 01 Day
Last follow-up date
2014 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information 9th Japan Research Association for Immunotherapeutics(2012.2.18)
13th Central European Lung Cancer Conference (2012.6.24-27)
16th Japanese Association of Cancer Immunology(2012.7.26-28)
15th World Conference on Lung Cancer
(2013.10.27-30)
54th The Japan Lung Cancer Society
(2013.11.21-22)

Management information
Registered date
2011 Year 06 Month 14 Day
Last modified on
2014 Year 05 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006825

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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