Combination of Local Therapy and Target Therapy for Brain... | NCT05616377

Studies
Combination of Local Therapy and Target Therapy for Brain Metastases With EGFR Mutation

NCT05616377

Sponsor

Sun Yat-sen University

Status

Unknown status

Last Update Posted

Nov 15, 2022Actual

Enrollment

2,000Estimated

Phase

Not provided

Conditions

Brain Metastases

Interventions

Surgery or Radiotherapy
before or after target therapy

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 20, 2022Estimated

Primary Completion Date

Aug 20, 2023Estimated

Completion Date

Nov 20, 2024Estimated

First Submitted Date

Nov 8, 2022

First Submission Date that Met QC Criteria

Nov 8, 2022

First Posted Date

Nov 15, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 8, 2022

Last Update Posted Date

Nov 15, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this observational study is to learn about the survival benefit of local therapy combination with target therapy in lung cancer brain metastases with EGFR mutation. The main questions it aims to answer are:

Is local therapy performed before or after target therapy would provide survival benefit ?
What kind of local therapy combining with target therapy would provide survival benefit, neurosurgical resection or radiotherapy?

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
target therapy + local therapy group vs target therapy alone group			Other: Surgery or Radiotherapy
local therapy before target therapy group vs local therapy after target therapy group			Other: before or after target therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Surgery or Radiotherapy	Other	Participants who underwent target therapy and surgery or radiotherapy were divided into target therapy + local therapy group. Participants who underwent target therapy alone were divided into target therapy alone group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
OS	Overall survival	From date of first follow-up until the date of documented death from any cause, assessed up to 120 months

Secondary Outcomes

Measure	Description	Time Frame
PFS	Progression-free survival	From date of first follow-up until the date of first documented progression, assessed up to 120 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Evidence of pathological diagnosis of primary tumor.
Brain metastases confirmed by enhanced magnetic resonance imaging.
Gene test indicated that EGFR mutation.
Complete clinical information.

Exclusion Criteria:

If surgical treatment is accepted, the surgical treatment is not tumor resection, but ventricle puncture, biopsy and other non-tumor reducing surgery.
Patients with 2 or more types of tumors.
Incomplete clinical information.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Hospital clients from Sun Yat-sen University Cancer Center, Guangxi Medical University Cancer Hospital, The People's Hospital Of Guangxi Zhuang Autonomous Region, and the First Affiliated Hospital of Guangxi Medical University will be selected.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lun Liang, PHD	Contact	18277186779		lianglun@sysucc.org.cn

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001932	Brain Neoplasms

Ancestor Terms

ID	Term
D016543	Central Nervous System Neoplasms
D009423	Nervous System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013514	Surgical Procedures, Operative
D011878	Radiotherapy
D007854	Lead

Ancestor Terms

ID	Term
D013812	Therapeutics
D019216	Metals, Heavy
D004602	Elements
D007287	Inorganic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided