UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003523 |
|---|---|
| Receipt number | R000004271 |
| Scientific Title | Vignette study for Treatment Selection in Patients with Non-small-Cell Lung Cancer Harboring Epidermal Growth Factor Receptor Mutations (LOGIK-0903) |
| Date of disclosure of the study information | 2010/04/22 |
| Last modified on | 2013/04/24 09:17:27 |
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Basic information
Public title
Vignette study for Treatment Selection in Patients with Non-small-Cell Lung Cancer Harboring Epidermal Growth Factor Receptor Mutations (LOGIK-0903)
Acronym
Vignette Study for Treatment Selection in Patients with Non-small-Cell Lung Cancer Harboring Epidermal Growth Factor Receptor Mutations (LOGIK-0903)
Scientific Title
Vignette study for Treatment Selection in Patients with Non-small-Cell Lung Cancer Harboring Epidermal Growth Factor Receptor Mutations (LOGIK-0903)
Scientific Title:Acronym
Vignette Study for Treatment Selection in Patients with Non-small-Cell Lung Cancer Harboring Epidermal Growth Factor Receptor Mutations (LOGIK-0903)
Region
| Japan |
Condition
Condition
Non-Small-Cell Lung Cancer
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
1) To investigate which treatment a patient will select between EGFR-TKI and standard doublet chemotherapy, and the reason why patients select each treatment.
2) To investigate the relationship between patient's insight and QOL/HADS score(QOL:FACT-L, HADS: Score for anxiety)
3) To seek any potential gap in treatment selection among patient, physician and other medical staff.
Basic objectives2
Others
Basic objectives -Others
1) To investigate which treatment a patient will select between EGFR-TKI and standard doublet chemotherapy, and the reason why patients select each treatment.
2) To investigate the relationship between patient's insight and QOL/HADS score(QOL:FACT-L, HADS: Score for anxiety)
3) To seek any potential gap in treatment selection among patient, physician and other medical staff.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
To investigate the reason for treatment selection by patients, physician or medical staff.
Key secondary outcomes
To investigate any correlation between patient treatment choice and FACT-L or HADS
To explore any gap in treatment choice between patients and physicians or medical staff.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who are proven non-small cell lung cancer harboring EGFR mutations, acceptable for drug treatment and with written informed consent for this study
2) Doctors or Medical staff working on lung cancer treatment with written informed consent for this study
Key exclusion criteria
1) Patients who have previously treated with standard platinum doublet chemotherapy, single chemotherapy for elderly or EGFR-TKI
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukito Ichinose |
Organization
Kyushu Cancer Center
Division name
Department of Thoracic Oncology
Zip code
Address
3-1-1 Notame, Minami-ku, Fukuoka, 811-1395, Japan
TEL
092-541-3231
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jiichiro Sasaki |
Organization
Faculty of Medicine, Kitasato University
Division name
Department of Respiratory Medicine
Zip code
Address
1-15-1 Kitasato, Minami-ku, Sagamihara-city, Kanagawa, 252-0374, Japan
TEL
042-778-6412
Homepage URL
saji@med.kitasato-u.ac.jp
Sponsor or person
Institute
Lung Oncology Group in Kyushu, Japan (LOGIK)
Institute
Department
Personal name
Funding Source
Organization
Clinical Research Support Center Kyushu
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
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
飯塚病院呼吸器内科（福岡県）
大分県立病院呼吸器外科（大分県）
長崎大学熱研内科(長崎県)
川内市医師会立市民病院呼吸器内科(鹿児島県)
浜の町病院呼吸器内科（福岡県）
長崎市立市民病院内科（長崎県）
九州大学呼吸器科（福岡県）
産業医科大学呼吸器内科（福岡県）
国立病院機構福岡東医療センター呼吸器科（福岡県）
国立病院機構九州がんセンター呼吸器腫瘍科（福岡県）
熊本市民病院呼吸器科（熊本県）
福岡大学筑紫病院（福岡県）
熊本大学呼吸器内科（熊本県）
佐賀大学血液・呼吸器・腫瘍内科（佐賀県）
熊本医療センター呼吸器内科（熊本県）
日本赤十字社長崎原爆病院呼吸器内科（長崎県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 04 | Month | 22 | 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
Completed
Date of protocol fixation
| 2009 | Year | 12 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2012 | Year | 12 | Month | 28 | Day |
Date trial data considered complete
| 2012 | Year | 12 | Month | 28 | Day |
Date analysis concluded
| 2013 | Year | 01 | Month | 24 | Day |
Other
Other related information
1) To investigate which treatment a patient will select between EGFR-TKI and standard doublet chemotherapy, and the reason why patients select each treatment.
Management information
Registered date
| 2010 | Year | 04 | Month | 22 | Day |
Last modified on
| 2013 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004271
