UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002044 |
|---|---|
| Receipt number | 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 10:13:35 |
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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
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
itachi02@imed3.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Respiratory Medicine, Allergy and Rheumatic Diseases, Osaka University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002491
