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

Brain Metastases Clinical Trial

— CLTBME  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05616377
• Other study ID #: EGFR+BM
• Status: Not yet recruiting
• Start date: November 20, 2022
• Est. completion date: November 20, 2024

Study information

• Verified date: November 2022
• Source: Sun Yat-sen University
• Contact: Lun Liang, PHD
• Phone: 18277186779
• Email: lianglun[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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?

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2000
• Est. completion date: November 20, 2024
• Est. primary completion date: August 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Metastases
• Brain Neoplasms
• Neoplasm Metastasis

Intervention

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
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	OS	Overall survival	From date of first follow-up until the date of documented death from any cause, assessed up to 120 months
Secondary	PFS	Progression-free survival	From date of first follow-up until the date of first documented progression, assessed up to 120 months