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

November 8, 2022 updated by: Yonggao Mou, Sun Yat-sen University

Survival Benefit of Combination of Local Therapy and Target Therapy for Brain Metastases With EGFR Mutation: A Multicenter Retrospective Study

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?

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
target therapy + local therapy group vs target therapy alone group
Other: Surgery or Radiotherapy
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
local therapy before target therapy group vs local therapy after target therapy group
Other: before or after target therapy
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

November 20, 2022

Primary Completion (ANTICIPATED)

August 20, 2023

Study Completion (ANTICIPATED)

November 20, 2024

Study Registration Dates

First Submitted

November 8, 2022

First Submitted That Met QC Criteria

November 8, 2022

First Posted (ACTUAL)

November 15, 2022

Study Record Updates

Last Update Posted (ACTUAL)

November 15, 2022

Last Update Submitted That Met QC Criteria

November 8, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EGFR+BM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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