UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046961 |
|---|---|
| Receipt number | R000053579 |
| Scientific Title | A retrospective study evaluating effectiveness of primary brain radiotherapy with TKI for driver gene mutation-positive advanced non-small cell lung cancer with asymptomatic brain metastases. |
| Date of disclosure of the study information | 2022/02/21 |
| Last modified on | 2022/02/21 13:37:05 |
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Basic information
Public title
A retrospective study evaluating effectiveness of primary brain radiotherapy with TKI for driver gene mutation-positive advanced non-small cell lung cancer with asymptomatic brain metastases.
Acronym
A retrospective study evaluating effectiveness of primary brain radiotherapy with TKI for driver gene mutation-positive advanced non-small cell lung cancer with asymptomatic brain metastases.
Scientific Title
A retrospective study evaluating effectiveness of primary brain radiotherapy with TKI for driver gene mutation-positive advanced non-small cell lung cancer with asymptomatic brain metastases.
Scientific Title:Acronym
A retrospective study evaluating effectiveness of primary brain radiotherapy with TKI for driver gene mutation-positive advanced non-small cell lung cancer with asymptomatic brain metastases.
Region
| Japan |
Condition
Condition
non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Investigate which of TKI monotherapy and TKI / head radiotherapy combination therapy prolongs intracranial progression free survival and overall survival in patients with driver gene mutation-positive non-small cell lung cancer with brain metastases.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
intracranial progression free survival
Key secondary outcomes
overall survival, best overall response of intracranial lesions, time to onset of central nervous system symptoms, TKI treatment period, progression free survival, best overall response, safety of head radiation therapy
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. Pathologically diagnosed as non-small cell lung cancer.
2. Driver gene positive has been confirmed and treated with the corresponding TKI.
3. A head imaging examination is performed before the first use of TKI.
4. Have brain metastases on first use of TKI.
5. Informed consent.
Key exclusion criteria
1. The physician has determined that it is inappropriate.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Takae |
| Middle name | |
| Last name | Okuno |
Organization
Shimane University Hospital
Division name
Medical Oncology and Respiratory Medicine
Zip code
6938501
Address
89-1 Enya-cho Izumo-shi shimane, Japan
TEL
0853202580
takae007@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Takae |
| Middle name | |
| Last name | Okuno |
Organization
Shimane University Hospital
Division name
Medical Oncology and Respiratory Medicine
Zip code
6938501
Address
89-1 Enya-cho Izumo-shi shimane, Japan
TEL
0853202580
Homepage URL
takae007@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University Hospital
Institute
Department
Personal name
Funding Source
Organization
Shimane University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shimane University Hospital
Address
89-1 Enya-cho Izumo-shi shimane, Japan
Tel
0853202580
takaegame007@yahoo.co.jp
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
| 2022 | Year | 02 | Month | 21 | 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
| 2021 | Year | 12 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2022 | Year | 02 | Month | 21 | Day |
Last modified on
| 2022 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053579
