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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000002044
Receipt No. R000002491
Scientific Title The Utility of PET/CT in Erlotinib treatment for Non-Small Cell cancer
Date of disclosure of the study information 2009/06/08
Last modified on 2009/06/04

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Basic information
Public title The Utility of PET/CT in Erlotinib treatment for Non-Small Cell cancer
Acronym The Utility of PET/CT in Erlotinib treatment for Non-Small Cell cancer
Scientific Title The Utility of PET/CT in Erlotinib treatment for Non-Small Cell cancer
Scientific Title:Acronym The Utility of PET/CT in Erlotinib treatment for Non-Small Cell cancer
Region
Japan

Condition
Condition Non-small cell lung cancer
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To evaluate whether f FDG uptake 2 days after erlotinib administration can predict the overall response of erlotinib for NSCLC
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Relationship between uptake of FDG 2 days after the erlotinib administration and tumor size on CT
Key secondary outcomes OS, PFS

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Device,equipment
Interventions/Control_1 PET/CT 2 days after erlotinib administration
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) NSCLC
2) no history of treatment of EGFR-TKI
3) At least one measurable lesion
4) Age>20 years
5) Performance status(PS) of 0 to 2
6) Written informed consent
Key exclusion criteria 1)History of radiation therapy for primary site
2)Severe infection
3)Bowel obstruction
4)Interstitioal pneumonia or lung fibrosis
5)History of any thoracic radiation therapy
6)Active concomitant malignancy
7)Sever heart disease
8)No regulatory condition because of psychological disease
9)Pregnant women or somen willing child-bearing
10)inadequate condition siagnosed by primary physician
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Isao Tachibana
Organization Osaka University Graduate School of Medicine
Division name Department of Respiratory Medicine, Allergy and Rheumatic Diseases
Zip code
Address 2-2 Yamadaoka, Suita, Osaka
TEL 06-6879-3831
Email

Public contact
Name of contact person
1st name
Middle name
Last name Isao Tachibana
Organization Osaka University Graduate School of Medicine
Division name Department of Respiratory Medicine, Allergy and Rheumatic Diseases
Zip code
Address 2-2 Yamadaoka, Suita, Osaka
TEL 06-6879-3831
Homepage URL
Email itachi02@imed3.med.osaka-u.ac.jp

Sponsor
Institute Department of Respiratory Medicine, Allergy and Rheumatic Diseases, Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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
2009 Year 06 Month 08 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 Preinitiation
Date of protocol fixation
2009 Year 03 Month 23 Day
Date of IRB
Anticipated trial start date
2009 Year 06 Month 01 Day
Last follow-up date
2011 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 06 Month 04 Day
Last modified on
2009 Year 06 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002491

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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