Sequence of Radiation and Targeted Therapy in Brain Metastases

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ClinicalTrials.gov Identifier: NCT04832672

Recruitment Status : Completed

First Posted : April 6, 2021

Last Update Posted : April 6, 2021

Sponsor:

Information provided by (Responsible Party):

Jianping Xiao, Chinese Academy of Medical Sciences

Study Description

Brief Summary:

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.

Condition or disease
The Optimal Sequence of Radiotherapy and Systematic Tyrosine Kinase Inhibitors in Treating Brain Metastases

Study Design

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Study Type :	Observational
Actual Enrollment :	570 participants
Observational Model:	Cohort
Time Perspective:	Retrospective
Official Title:	The Optimal Sequence of Intracranial Radiotherapy Compared to Systematic Tyrosine Kinase Inhibitors for Gene-driven Brain Metastases in Targeted Treatment Era
Actual Study Start Date :	October 1, 2010
Actual Primary Completion Date :	March 1, 2021
Actual Study Completion Date :	March 1, 2021

Groups and Cohorts

Group/Cohort
The upfront radiotherapy group
The upfront targeted-therapy group

Outcome Measures

Primary Outcome Measures :

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 ]
The survival time of patients before any intracranial progression

Secondary Outcome Measures :

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 ]
The survival time of patients
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

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients who underwent hypofractionated stereotactic radiotherapy planning at our institution from October 2010 to October 2020

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04832672

Locations

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China, Beijing
Chinese Academy of Medical Sciences
Beijing, Beijing, China, 100021

Sponsors and Collaborators

Chinese Academy of Medical Sciences

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Yang S, Xiao J, Liu Q, Zhang Y, Bi N, Huang X, Chen X, Wang K, Ma Y, Deng L, Wang W, Zhao R, Li J, Yi J, Wang S, Li Y. The Sequence of Intracranial Radiotherapy and Systemic Treatment With Tyrosine Kinase Inhibitors for Gene-Driven Non-Small Cell Lung Cancer Brain Metastases in the Targeted Treatment Era: A 10-Year Single-Center Experience. Front Oncol. 2021 Oct 14;11:732883. doi: 10.3389/fonc.2021.732883. eCollection 2021.

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Responsible Party:	Jianping Xiao, Professor, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier:	NCT04832672
Other Study ID Numbers:	NCC-005269
First Posted:	April 6, 2021 Key Record Dates
Last Update Posted:	April 6, 2021
Last Verified:	April 2021

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Jianping Xiao, Chinese Academy of Medical Sciences:


Brain metastases Radiotherapy Targeted therapy

Additional relevant MeSH terms:

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Neoplasm Metastasis Neoplasms, Second Primary Brain Neoplasms Neoplastic Processes Neoplasms Pathologic Processes	Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Brain Diseases Central Nervous System Diseases Nervous System Diseases

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