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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000007525
Receipt No. R000008887
Scientific Title Randomized phase III trial of adjuvant chemo-immunotherapy with dendritic cells and activated killer cells in patients with resected primary lung cancer patients
Date of disclosure of the study information 2012/04/01
Last modified on 2015/04/22

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Basic information
Public title Randomized phase III trial of adjuvant chemo-immunotherapy with dendritic cells and activated killer cells in patients with resected primary lung cancer patients
Acronym Immunotherapy for post-surgical lung cancer patients
Scientific Title Randomized phase III trial of adjuvant chemo-immunotherapy with dendritic cells and activated killer cells in patients with resected primary lung cancer patients
Scientific Title:Acronym Immunotherapy for post-surgical lung cancer patients
Region
Japan

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

Objectives
Narrative objectives1 To compare the survival and recurrence free survival in the phase III study of post surgical lung cancer patients. group A: patients who received postsurgical immunotherapy and chemotherapy with activated killer cells and dendritic cells . Group B: patients who received chemotherapy alone.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes 2 year survival,5 year survival
Key secondary outcomes recurrence free survival, safety,
seide effect

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 group A: immunotherapy and chemotherapy
chemotherapy: CBDCA+GEM orCBDCA+PTX or CBDCA+PEM 4 courses every month
2 courses of Induction chemotherapy are applied for advanced cases Immunotherapy: every month for 6 courses and every 2 months for 2 years thereafter
Interventions/Control_2 group B chemotherapy
chemotherapy: CBDCA+GEM orCBDCA+PTX or CBDCA+PEM 4 courses every month
2-3 courses of Induction chemotherapy are applied for advanced cases
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

Not applicable
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria 1)surgically resected primary non-small cell lung cancer patients
2) stage IIA -IV with no residual cancer after surgery
3) PS=0 or 1
4)more than 3X109(3 billion) activated killer cells are available from regional lymoh nodes for one course of immunotherapy
5) postsurgial treatment can be started within 2 months after surgery
6)chief organ functions are preserved
12000mm3 > WBC> 3000/mm3
Plt >100,000/mm3
Hb> 8.0g/dl TBil<2mg/dl
AST,ALT <100IU/L
Creatinin <1.2mg/dl
9)written informed consent are obtained
Key exclusion criteria 1 with other active cancer
2 with viral infection (HIV,HBS,HCV)
3 small cell lung cancer( combied SCLC are included for the study)
Target sample size 160

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideki Kimura M.D.
Organization Chiba Cancer Center
Division name Division of thoaracic diseases
Zip code
Address 666-2 Nitona-cho, Chu-O-ku ,Chiba city Chiba
TEL 043-264-5431
Email h.kimura@chiba-saiseikai.com

Public contact
Name of contact person
1st name
Middle name
Last name Hideki Kimura M.D.
Organization Chiba Cancer Center
Division name DIvision of Thoracic Diseases
Zip code
Address 666-2 Nitona-cho, Chu-o-ku ,Chiba City,Chiba
TEL 043-264-5431
Homepage URL
Email hkimura@chiba-cc.jp

Sponsor
Institute Chiba Cancer Center
Institute
Department

Funding Source
Organization Chiba Cancer Center
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization None

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
2012 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially 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 Enrolling by invitation
Date of protocol fixation
2007 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2007 Year 04 Month 01 Day
Last follow-up date
2013 Year 03 Month 01 Day
Date of closure to data entry
2013 Year 03 Month 01 Day
Date trial data considered complete
2013 Year 03 Month 01 Day
Date analysis concluded
2013 Year 04 Month 01 Day

Other
Other related information

Management information
Registered date
2012 Year 03 Month 18 Day
Last modified on
2015 Year 04 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008887

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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