Brain MetastasesNCT03338075
FSRT Combined With TMZ for Large BMs: a PSM Study
An observational study of Brain Metastases and Radiotherapy, run by Chinese Academy of Medical Sciences.
Trial summary
A propensity- matched study was conducted to investigate the feasibility and safety of adding temozolomide to hypofractionated stereotactic radiotherapy for large brain metastases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Metastases, Radiotherapy, Chemotherapy
- What is being tested?
- fractionated stereotactic radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 1 Aug 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with large brain metastases of more than 6 cc.
Who may be able to join
- (1) primary tumor was pathologically diagnosed and brain metastases were confirmed by gadolinium-enhanced magnetic resonance imaging (MRI) ; (2) age 18 years or older (3) KPS ≥60, or KPS ≥50 but symptomatically caused by BMs; (4) the large lesions haven't treated with surgery or SRT.
Who cannot join
- (1) KPS <60 but not caused by BMs; (2) the large lesions have been treated with surgery or SRT.
About this study
Official title: Fractionated Stereotactic Radiotherapy Combined With Temozolomide for Large Brain Metastases: a Propensity-matched Study
A propensity- matched study was conducted to investigate the feasibility and safety of adding temozolomide to hypofractionated stereotactic radiotherapy for large brain metastases.
Read the detailed description
A previous single arm phase II trial of our institution has shown that HFSRT combined with concurrent TMZ was safe and efficient for patients with BMs of ≥ 6cc in volume. The 1-year local control and overall survival rate was better than the results of a retrospective study using HFSRT alone in treating BMs of ≥ 3cm in diameter. Thus, we hypothesized that adding TMZ to HFSRT should translate to substantive benefits in clinical outcomes compared to HFSRT alone. Propensity score matching method was adopted to decrease potential bias in this retrospective study.
- Conditions
- Brain Metastases, Radiotherapy, Chemotherapy
- Being tested
- fractionated stereotactic radiotherapy
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fractionated stereotactic radiotherapyRadiation
Also called drugs
The regular prescription doses were 52 Gy in 13 fractions or 52.5 Gy in 15 fractions.
| Study group | Role | What they receive |
|---|---|---|
| CRT group | patients with brain metastases of more than 6 cc and treated with fractionated stereotactic radiotherapy plus concomitant Temozolomide. Receives: Radiation: fractionated stereotactic radiotherapy | |
| RT group | patients with brain metastases of more than 6 cc and treated with fractionated stereotactic radiotherapy alone. Receives: Radiation: fractionated stereotactic radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local tumor control rate (LTCR)
the control rate of treated lesions
Measured: 3 months after radiation
Secondary outcomes (5)
Intracranial progression- free survival (IPFS)
the interval from the beginning of radiation to any intracranial progression
Measured: up to 1 year
Local recurrence- free survival (LRFS)
the time from the beginning of radiation to local faliure.
Measured: up to 1 year
Overall survival (OS)
the time from the beginning of radiation to follow-up or death
Measured: up to 3 years
Progression- free survival (PFS)
the interval from the beginning of HFSRT to any progression of tumor.
Measured: up to 1 year
Brain metastasis-specific survival (BMSS)
the internal from the beginning of radiation to death that caused by brain metastases.
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2017
- Study start1 Jan 2016
- Primary completion1 Aug 2017
- Study completion1 Aug 2017
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.
- 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
- 72 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
- Investigators
- Jianping Xiao, Dr, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03338075
- Sponsor's protocol ID
- CH-H&N-004
- Status last verified
- Nov 2017
- First submitted
- 7 Nov 2017
- Last updated
- 9 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fractionated Stereotactic Radiotherapy Combined With Temozolomide for Large Brain Metastases: a Propensity-matched Study
- ClinicalTrials.gov ID
- NCT03338075
- Acronym / sponsor ID
- CH-H&N-004
- Conditions
- Brain Metastases, Radiotherapy, Chemotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Aug 2017 (actual)
- Study completion
- 1 Aug 2017 (actual)
- First posted
- 9 Nov 2017 (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.
A propensity- matched study was conducted to investigate the feasibility and safety of adding temozolomide to hypofractionated stereotactic radiotherapy for large brain metastases.
Detailed description
A previous single arm phase II trial of our institution has shown that HFSRT combined with concurrent TMZ was safe and efficient for patients with BMs of ≥ 6cc in volume. The 1-year local control and overall survival rate was better than the results of a retrospective study using HFSRT alone in treating BMs of ≥ 3cm in diameter. Thus, we hypothesized that adding TMZ to HFSRT should translate to substantive benefits in clinical outcomes compared to HFSRT alone. Propensity score matching method was adopted to decrease potential bias in this retrospective study.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CRT group | – | Radiation: fractionated stereotactic radiotherapypatients with brain metastases of more than 6 cc and treated with fractionated stereotactic radiotherapy plus concomitant Temozolomide. |
| RT group | – | Radiation: fractionated stereotactic radiotherapypatients with brain metastases of more than 6 cc and treated with fractionated stereotactic radiotherapy alone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with large brain metastases of more than 6 cc.
Key inclusion criteria (1 listed)
- (1) primary tumor was pathologically diagnosed and brain metastases were confirmed by gadolinium-enhanced magnetic resonance imaging (MRI) ; (2) age 18 years or older (3) KPS ≥60, or KPS ≥50 but symptomatically caused by BMs; (4) the large lesions haven't treated with surgery or SRT.
Key exclusion criteria (1 listed)
- (1) KPS <60 but not caused by BMs; (2) the large lesions have been treated with surgery or SRT.
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 |
|---|---|---|
| fractionated stereotactic radiotherapyAlso: drugsThe regular prescription doses were 52 Gy in 13 fractions or 52.5 Gy in 15 fractions. | Radiation | CRT group, RT group |
Primary outcome
Local tumor control rate (LTCR)
Time frame: 3 months after radiation
the control rate of treated lesions
5 secondary outcomes
Intracranial progression- free survival (IPFS)
Time frame: up to 1 year
Local recurrence- free survival (LRFS)
Time frame: up to 1 year
Overall survival (OS)
Time frame: up to 3 years
Progression- free survival (PFS)
Time frame: up to 1 year
Brain metastasis-specific survival (BMSS)
Time frame: up to 1 year
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 9 Nov 2017.
- Individual participant dataSharing planned: No
Related trials for Brain Metastases
RecruitingObservational study
Dual Energy CT - a Tool for Delineation of Tumor and Organs at Risk in Radiotherapy
Brain Metastases, Bone Metastases
Not yet recruitingPhase 2
Study of Trastuzumab Deruxtecan in Combination With Stereotactic Radiosurgery in Patients With HER2-Positive Metastatic Breast Cancer and First Diagnosis of Brain Metastases (HERBRAIN)
Breast Cancer (Advanced/Metastatic)
RecruitingPhase 4
Brain [18F]-FES PET/CT in Patients With Estrogen-Receptor Positive Breast Cancer
Breast Cancer, Brain Metastases
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
Not yet recruitingObservational study
Impact of a Radiologic and Immunologic Signature on Cerebral Efficacy of Treatments in Lung Cancers With Brain Metastasis
Carcinoma, Non-Small-Cell Lung
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.
Jianping Xiao, Dr principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Metastases and Radiotherapy, run by Chinese Academy of Medical Sciences.
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 1 inclusion and 1 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 9 Nov 2017. 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?
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?
Local tumor control rate (LTCR) (time frame: 3 months after radiation). 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 9 Nov 2017.