UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007525 |
|---|---|
| Receipt number | 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 07:54:19 |
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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
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
hkimura@chiba-cc.jp
Sponsor or person
Institute
Chiba Cancer Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008887
