UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000637 |
|---|---|
| Receipt number | R000000763 |
| Scientific Title | Clinical study of a combined use of Gefitinib and autologous lymphocyte-activated killer cells (LAK) therapy for advanced non-small cell lung cancer. |
| Date of disclosure of the study information | 2007/03/16 |
| Last modified on | 2009/06/09 11:51:33 |
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Basic information
Public title
Clinical study of a combined use of Gefitinib and autologous lymphocyte-activated killer cells (LAK) therapy for advanced non-small cell lung cancer.
Acronym
Clinical study of a combined use of Gefitinib and autologous lymphocyte-activated killer cells (LAK) therapy for advanced non-small cell lung cancer.
Scientific Title
Clinical study of a combined use of Gefitinib and autologous lymphocyte-activated killer cells (LAK) therapy for advanced non-small cell lung cancer.
Scientific Title:Acronym
Clinical study of a combined use of Gefitinib and autologous lymphocyte-activated killer cells (LAK) therapy for advanced non-small cell lung cancer.
Region
| Japan |
Condition
Condition
non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate efficacy and safety on LAK therapy for non-small cell lung cancer patients whose anti-tumor effect of Gefitinib is SD.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
Survival rate
Progression-free survival
Antitumor effect
Improvement of tumor-related markers
QOL(FACT-BRM)
Safety
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 |
Interventions/Control_1
Autologous Lymphocyte-Activated Killer cells (LAK)
Gefitinib
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
Patients who are aged 20-80 years ; who are judged SD for Gefitinib therapy based on RECIST; who have no serious abnormality in bone marrow, liver and/or renal functions, and whose PS is 0-1 ; whose life-expectancy is more than 6 months.
Key exclusion criteria
Patients who have: previous history of hypersensitivity to Gefitinib, uncontrolled infections, active autoimmune diseases, and serious cardiac disease; who have received continuous systemic steroids; who are pregnant, to be pregnant, or nursing mothers, and whom principle investigator or co-investigator judged to be inappropriate to participate in this study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhisa Takahashi |
Organization
Juntendo University, School of Medicine
Division name
Department of Respiratory Medicine
Zip code
Address
2-1-1 Hongo,Bunkyo-Ku,Tokyo
TEL
03-5802-1063
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Juntendo University, School of Medicine
Division name
Department of Respiratory Medicine
Zip code
Address
2-1-1 Hongo,Bunkyo-Ku,Tokyo
TEL
03-5802-1063
Homepage URL
Sponsor or person
Institute
Juntendo University, School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Medinet Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Shinyokohama medical clinic
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
| 2007 | Year | 03 | Month | 16 | 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
Terminated
Date of protocol fixation
| 2007 | Year | 01 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2009 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 03 | Month | 15 | Day |
Last modified on
| 2009 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000763
