Sequence of Radiation and Targeted Therapy in Brain Metastases
April 5, 2021 updated by: Jianping Xiao, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
The Optimal Sequence of Intracranial Radiotherapy Compared to Systematic Tyrosine Kinase Inhibitors for Gene-driven Brain Metastases in Targeted Treatment Era
The investigators conducted a single institutional, retrospective cohort study to demonstrate the appropriate treatment strategy of upfront intracranial radiotherapy or upfront targeted therapy in patients with brain metastases, including an assessment of its feasibility and toxicity.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
570
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Beijing
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Beijing, Beijing, China, 100021
- Chinese Academy of Medical Sciences
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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
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients who underwent hypofractionated stereotactic radiotherapy planning at our institution from October 2010 to October 2020
Description
Inclusion Criteria:
- Had histologically proven primary cancer.
- Had newly diagnosed brain metastases in contrast-enhanced MRI.
- Brain metastases focus should be measurable.
- All the patients should safely receive radiotherapy and/or systematic tyrosine kinase inhibitors.
- Karnofsky performance score (KPS) ≥60 or KPS ≥40, but only caused by brain metastases.
Exclusion Criteria:
- Patients with prior intracranial local treatments, such as surgery and radiotherapy without dose prescription in detail
- Patients with leptomeningeal metastases at first diagnosis.
- Had synchronous or metachronous malignancies that might affect survival.
- Had severe systemic diseases, abnormal conditions that might lead to incoordinate behavior during the implementation of clinical measures.
- Had incomplete sociodemographic and/or clinicopathologic baseline data
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 |
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The upfront radiotherapy group
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The upfront targeted-therapy group
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intracranial progression-free survival
Time Frame: The interval from the start of initial intracranial treatment to first documented intracranial progression, or date of death from any cause, whichever came first, assessed up to 3 to 5 years
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The survival time of patients before any intracranial progression
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The interval from the start of initial intracranial treatment to first documented intracranial progression, or date of death from any cause, whichever came first, assessed up to 3 to 5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall survival
Time Frame: The time from the date of initial intracranial treatment until death from any cause or censored on the last follow-up, whichever came first, assessed up to 3 to 5 years
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The survival time of patients
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The time from the date of initial intracranial treatment until death from any cause or censored on the last follow-up, whichever came first, assessed up to 3 to 5 years
|
|
Brain metastasis-specific survival
Time Frame: The interval from the start of initial intracranial treatment to death from brain metastases or censored on the last follow-up, whichever came first, assessed up to 3 to 5 years
|
The survival time of patients dead from brain metastases
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The interval from the start of initial intracranial treatment to death from brain metastases or censored on the last follow-up, whichever came first, assessed up to 3 to 5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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 (Actual)
October 1, 2010
Primary Completion (Actual)
March 1, 2021
Study Completion (Actual)
March 1, 2021
Study Registration Dates
First Submitted
April 2, 2021
First Submitted That Met QC Criteria
April 5, 2021
First Posted (Actual)
April 6, 2021
Study Record Updates
Last Update Posted (Actual)
April 6, 2021
Last Update Submitted That Met QC Criteria
April 5, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCC-005269
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.