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

Not yet recruiting

• Conditions: Brain Metastases
• Interventions: Other: Surgery or Radiotherapy; Other: before or after target therapy

• Registration Number: NCT05616377
• Lead Sponsor: Sun Yat-sen University

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 available

Study Timeline

• Status Verified: 2022-11
• Study First Submitted: 2022-11-08
• Study First Submitted QC: 2022-11-08
• Last Update Submitted: 2022-11-08
• Study First Posted: 2022-11-15
• Last Update Posted: 2022-11-15
• Study Start: 2022-11-20
• Primary Completion: 2023-08-20
• Study Completion: 2024-11-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
target therapy + local therapy group vs target therapy alone group	Surgery or Radiotherapy	-
local therapy before target therapy group vs local therapy after target therapy group	before or after target therapy	-

Primary Outcome Measures

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

Secondary Outcome Measures

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