Metastasis BrainCKBrainMetaNCT03286023
Stereotactic Radiotherapy for Brain Metastases
An observational study of Metastasis Brain, run by Centre Francois Baclesse, Luxembourg at 1 site in Luxembourg.
Trial summary
Stereotactic radiotherapy is an innovative treatment enabling to target accurately brain metastases. The aim of this study is to evaluate tumoral response and acute and late toxicity of this treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastasis Brain
- What is being tested?
- stereotactic radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 110 participants
- Where
- 1 siteLuxembourg
- Study dates
- Oct 2014to Dec 2022
- 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 brain metastases
Who may be able to join
- Situation 1: in case of several cerebral metastases. In this case, the maximum of cerebral metastases is 3, and the maximum diameter of the largest can not exceed 3 cm. The other two ones can not exceed 1 cm or even maximum 2 cm in diameter for one of the two. The same principle will remain valid in the presence of 2 metastases.
- Situation 2: in the case of a single metastasis, the diameter should be a maximum of 3 cm
- Situation 3: in case of metastasis supposed to be radioresistant (renal adenocarcinoma, sarcoma, melanoma ...), only a single metastasis of not more than 3 cm in diameter will be accepted. A primary resection followed by radiotherapy will be preferred.
- Situation 4: In case of localization near a structure at risk (contact with anterior optical pathways, central nuclei or the brainstem or localization in these structures), a maximum number of 3 metastases may be accepted. However, that included in or close to the risk structure can not exceed 2 cm in diameter and the other two, located outside a risk structure will have a diameter not exceeding 1 or even maximum 2 cm.
- Situation 5: single metastasis of maximum 3 cm in a context of re-irradiation, the whole encephalon having already received the dose of 10 X 3 Gy or its biological equivalent of dose.
- Signed informed consent
Who cannot join
- Impossibility of performing an MRI or a CT-scan of the brain with injection of contrast agent
- Metastases greater than 3 cm at the start
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stereotactic Radiotherapy for Patients With Brain Metastases
Stereotactic radiotherapy is an innovative treatment enabling to target accurately brain metastases. The aim of this study is to evaluate tumoral response and acute and late toxicity of this treatment.
- Conditions
- Metastasis Brain
- Being tested
- stereotactic radiotherapy
- Keywords
- brain metastases, stereotactic radiation, cyberknife
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stereotactic radiotherapyRadiation
stereotactic radiotherapy for brain metastases
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic radiation | Stereotactic radiation for brain metastases Receives: Radiation: stereotactic radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of tumoral response
Evaluation of response using Magnetic resonance imaging (Recist criteria)
Measured: 4 weeks after treatment
Evaluation of tumoral response
Evaluation of response using Magnetic resonance imaging (Recist criteria)
Measured: 8 weeks after treatment
Secondary outcomes (1)
Evaluation of toxicity
Evaluation of toxicity using CTCAE v4.0
Measured: 1, 3, 6, 9, 12, 15 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2017
- Study startOct 2014
- Primary completionOct 2019
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastasis BrainStudies 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
- Prospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse, Luxembourg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03286023
- Sponsor's protocol ID
- CYM6 Brain metastases CFB 1
- Acronym
- CKBrainMeta
- Status last verified
- Jun 2022
- First submitted
- 7 Sep 2017
- Last updated
- 22 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic Radiotherapy for Patients With Brain Metastases
- ClinicalTrials.gov ID
- NCT03286023
- Acronym / sponsor ID
- CKBrainMeta / CYM6 Brain metastases CFB 1
- Conditions
- Metastasis Brain
- Keywords
- brain metastases, stereotactic radiation, cyberknife
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Centre Francois Baclesse, LuxembourgUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Oct 2019 (actual)
- Study completion
- Dec 2022 (estimated)
- First posted
- 18 Sep 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.
Stereotactic radiotherapy is an innovative treatment enabling to target accurately brain metastases. The aim of this study is to evaluate tumoral response and acute and late toxicity of this treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stereotactic radiation | – | Radiation: stereotactic radiotherapyStereotactic radiation for brain metastases |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with brain metastases
Key inclusion criteria (6 listed)
- Situation 1: in case of several cerebral metastases. In this case, the maximum of cerebral metastases is 3, and the maximum diameter of the largest can not exceed 3 cm. The other two ones can not exceed 1 cm or even maximum 2 cm in diameter for one of the two. The same principle will remain valid in the presence of 2 metastases.
- Situation 2: in the case of a single metastasis, the diameter should be a maximum of 3 cm
- Situation 3: in case of metastasis supposed to be radioresistant (renal adenocarcinoma, sarcoma, melanoma ...), only a single metastasis of not more than 3 cm in diameter will be accepted. A primary resection followed by radiotherapy will be preferred.
- Situation 4: In case of localization near a structure at risk (contact with anterior optical pathways, central nuclei or the brainstem or localization in these structures), a maximum number of 3 metastases may be accepted. However, that included in or close to the risk structure can not exceed 2 cm in diameter and the other two, located outside a risk structure will have a diameter not exceeding 1 or even maximum 2 cm.
- Situation 5: single metastasis of maximum 3 cm in a context of re-irradiation, the whole encephalon having already received the dose of 10 X 3 Gy or its biological equivalent of dose.
Key exclusion criteria (2 listed)
- Impossibility of performing an MRI or a CT-scan of the brain with injection of contrast agent
- Metastases greater than 3 cm at the start
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 |
|---|---|---|
| stereotactic radiotherapystereotactic radiotherapy for brain metastases | Radiation | Stereotactic radiation |
Primary outcome
Evaluation of tumoral response
Time frame: 4 weeks after treatment
Evaluation of response using Magnetic resonance imaging (Recist criteria)
Evaluation of tumoral response
Time frame: 8 weeks after treatment
Evaluation of response using Magnetic resonance imaging (Recist criteria)
1 secondary outcome
Evaluation of toxicity
Time frame: 1, 3, 6, 9, 12, 15 months after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
- Individual participant dataSharing planned: No
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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.
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 Metastasis Brain, run by Centre Francois Baclesse, Luxembourg at 1 site in Luxembourg.
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 6 inclusion and 2 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 22 Jun 2022. 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 Luxembourg. 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?
Results are not available in the source record.
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?
Evaluation of tumoral response (time frame: 4 weeks after treatment). The study lists 2 primary outcomes in all. 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 22 Jun 2022; AzTrials last refreshed its copy on 31 Oct 2026.