UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000000637
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email

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
Email

Sponsor
Institute Juntendo University, School of Medicine
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000763

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.