Brain MetastasesCLTBMENCT05616377
Combination of Local Therapy and Target Therapy for Brain Metastases With EGFR Mutation
An observational study of Brain Metastases, run by Sun Yat-sen University.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Brain Metastases
- What is being tested?
- Surgery or Radiotherapy and before or after target therapy
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- 20 Nov 2022to 20 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older 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.
Who may be able to join
- Evidence of pathological diagnosis of primary tumor.
- Brain metastases confirmed by enhanced magnetic resonance imaging.
- Gene test indicated that EGFR mutation.
- Complete clinical information.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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?
- Conditions
- Brain Metastases
- Being tested
- Surgery or Radiotherapy, before or after target therapy
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery or RadiotherapyOther
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 therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| target therapy + local therapy group vs target therapy alone group | Not described Receives: Other: Surgery or Radiotherapy | |
| local therapy before target therapy group vs local therapy after target therapy group | Not described Receives: Other: before or after target therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
OS
Overall survival
Measured: From date of first follow-up until the date of documented death from any cause, assessed up to 120 months
Secondary outcomes (1)
PFS
Progression-free survival
Measured: From date of first follow-up until the date of first documented progression, assessed up to 120 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2022
- Study start20 Nov 2022 (estimated)
- Primary completion20 Aug 2023 (estimated)
- Study completion20 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain MetastasesStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yonggao Mou, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05616377
- Sponsor's protocol ID
- EGFR+BM
- Acronym
- CLTBME
- Status last verified
- Nov 2022
- First submitted
- 8 Nov 2022
- Last updated
- 15 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survival Benefit of Combination of Local Therapy and Target Therapy for Brain Metastases With EGFR Mutation: A Multicenter Retrospective Study
- ClinicalTrials.gov ID
- NCT05616377
- Acronym / sponsor ID
- CLTBME / EGFR+BM
- Conditions
- Brain Metastases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 20 Nov 2022 (estimated)
- Primary completion
- 20 Aug 2023 (estimated)
- Study completion
- 20 Nov 2024 (estimated)
- First posted
- 15 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older 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.
Key inclusion criteria (4 listed)
- Evidence of pathological diagnosis of primary tumor.
- Brain metastases confirmed by enhanced magnetic resonance imaging.
- Gene test indicated that EGFR mutation.
- Complete clinical information.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgery or RadiotherapyParticipants 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 | Other | target therapy + local therapy group vs target therapy alone group |
| before or after target therapyParticipants 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. | Other | local therapy before target therapy group vs local therapy after target therapy group |
Primary outcome
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
1 secondary outcome
PFS
Time frame: From date of first follow-up until the date of first documented progression, assessed up to 120 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Metastases, run by Sun Yat-sen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lun Liang, PHD (18277186779, lianglun@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OS (time frame: From date of first follow-up until the date of documented death from any cause, assessed up to 120 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2022.