The Optimal Sequence of Radiotherapy and Systematic Tyrosine Kinase Inhibitors in Treating Brain MetastasesNCT04832672
Sequence of Radiation and Targeted Therapy in Brain Metastases
An observational study of The Optimal Sequence of Radiotherapy and Systematic Tyrosine Kinase Inhibitors in Treating Brain Metastases, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- The Optimal Sequence of Radiotherapy and Systematic Tyrosine Kinase Inhibitors in Treating Brain Metastases
- How many people
- 570 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2010to 1 Mar 2021
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent hypofractionated stereotactic radiotherapy planning at our institution from October 2010 to October 2020
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
About this study
Official title: 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.
- Keywords
- Brain metastases, Radiotherapy, Targeted 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.
| Study group | Role | What they receive |
|---|---|---|
| The upfront radiotherapy group | Not described | |
| The upfront targeted-therapy group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intracranial progression-free survival
The survival time of patients before any intracranial progression
Measured: 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 outcomes (2)
Overall survival
The survival time of patients
Measured: 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
The survival time of patients dead from brain metastases
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2021
- Study start1 Oct 2010
- Primary completion1 Mar 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for The Optimal Sequence of Radiotherapy and Systematic Tyrosine Kinase Inhibitors in Treating Brain MetastasesStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 570 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianping Xiao, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04832672
- Sponsor's protocol ID
- NCC-005269
- Status last verified
- Apr 2021
- First submitted
- 2 Apr 2021
- Last updated
- 6 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34722275
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Optimal Sequence of Intracranial Radiotherapy Compared to Systematic Tyrosine Kinase Inhibitors for Gene-driven Brain Metastases in Targeted Treatment Era
- ClinicalTrials.gov ID
- NCT04832672
- Acronym / sponsor ID
- NCC-005269
- Keywords
- Brain metastases, Radiotherapy, Targeted therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 570 participants (actual)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Oct 2010 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 6 Apr 2021 (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 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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The upfront radiotherapy group | – | – |
| The upfront targeted-therapy group | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent hypofractionated stereotactic radiotherapy planning at our institution from October 2010 to October 2020
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2021.
- Derived from this study: PubMed 34722275Yang 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.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of The Optimal Sequence of Radiotherapy and Systematic Tyrosine Kinase Inhibitors in Treating Brain Metastases, run by Chinese Academy of Medical Sciences at 1 site in China.
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 6 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04832672, which also lists 1 linked publication.
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 6 Apr 2021.