UMIN-CTR Clinical Trial

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
Email	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
Email	takae007@med.shimane-u.ac.jp

Sponsor
Institute	Shimane University Hospital
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053579