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

NCT05616377 | Unknown

• 1 other identifier: EGFR+BM
• Study Type: observational
• Target: 2,000
• Locations: 0 countries
• Sites: N/A

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?

Conditions

Brain Metastases

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• PFS

  From date of first follow-up until the date of first documented progression, assessed up to 120 months

Study Arms (2)

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

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

target therapy + local therapy group vs target therapy alone group

before or after target therapy OTHER

Participants who underwent surgery or radiotherapy before target therapy were divided into local therapy before target therapy group. Participants who underwent surgery or radiotherapy after target therapy were divided into local therapy after target therapy group.

local therapy before target therapy group vs local therapy after target therapy group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Surgical Procedures, Operative; Radiotherapy; Lead

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Metals, Heavy; Elements; Inorganic Chemicals; Metals

Central Study Contacts

Lun Liang, PHD

CONTACT

18277186779; lianglun@sysucc.org.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Neurosurgery

Study Record Dates

• First Submitted: November 8, 2022
• First Posted: November 15, 2022
• Study Start: November 20, 2022
• Primary Completion: August 20, 2023
• Study Completion: November 20, 2024
• Last Updated: November 15, 2022

Record last verified: 2022-11