UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010462 |
|---|---|
| Receipt number | R000011750 |
| Scientific Title | pharmacodynamic assay after single dose of gefitinib in resected adenocarcinoma of the lung |
| Date of disclosure of the study information | 2013/04/10 |
| Last modified on | 2021/04/18 19:59:20 |
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Basic information
Public title
pharmacodynamic assay after single dose of gefitinib in resected adenocarcinoma of the lung
Acronym
pharmacodynamic assay after single dose of gefitinib
Scientific Title
pharmacodynamic assay after single dose of gefitinib in resected adenocarcinoma of the lung
Scientific Title:Acronym
pharmacodynamic assay after single dose of gefitinib
Region
| Japan |
Condition
Condition
lung cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
We plan to investigate pharmacodynamic markers (apoptotic index, MIB-1 index, kinase activities) in surgical specimen of lung cancer after single dose administration of gefitinib two days before surgery, and compare these markers between EGFR mutation positive and negative cancers.
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
pharmacodynamic markers (apoptotic index, MIB-1 index, kinase activities) in surgical specimen
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
take a gefitinib(250mg/body) two days before surgery
Interventions/Control_2
no medication
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) histological or cytological confirmation of lung adenocarcinoma (NSCLC), class 4 or 5
2) planning of curative resection of NSCLC
3) non-smoker
4) 20 years or older
5) ECOG performance score of 0 or 1
6) informed written consent after understanding that this trial is not intended to treat the lung cancer
7) no prior therapy for NSCLC
8) preserved organ functions
Key exclusion criteria
1) past history of severe allegy
2) clinically significant psychological problem
3) past or present history of interstitial lung disease detected by computed tomography
4) HIV infection
5) inadequate patient judged by a attending doctor
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Narikazu |
| Middle name | |
| Last name | Boku |
Organization
St. Marianna University School of Medicine
Division name
Division of clinical oncology
Zip code
2160015
Address
2-16-1 Sugao Miyamae-Ku,Kawasaki,kanagawa,216-8511, JAPAN
TEL
+81-44-977-8111
n2izawa@gmail.com
Public contact
Name of contact person
| 1st name | naoki |
| Middle name | |
| Last name | izawa |
Organization
St. Marianna University School of Medicine
Division name
Division of clinical oncology
Zip code
2160015
Address
2-16-1 Sugao Miyamae-Ku,Kawasaki,kanagawa,216-8511, JAPAN
TEL
+81-44-977-8111
Homepage URL
n2izawa@gmail.com
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
No
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Shizuoka cancer center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St. Marianna University School of Medicine
Address
2-16-1 sugao miyamaeku, kawasaki
Tel
044-977-8111
n2izawa@gmail.com
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
聖マリアンナ医科大学
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 04 | Month | 10 | 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
| 2012 | Year | 12 | Month | 07 | Day |
Date of IRB
| 2012 | Year | 11 | Month | 14 | Day |
Anticipated trial start date
| 2013 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 02 | 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
| 2013 | Year | 04 | Month | 10 | Day |
Last modified on
| 2021 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011750
