Lung CancerMaskNCT02732769
Clinical Evaluation of the Treatment of Intellectual Metastases by Radiosurgery Gamma Knife by Means of a Support System by Mask.
A study testing GammaKnifePerfexion®, GammaKnifeIcon® and Efficast® in people with Lung Cancer and Brain Metastases, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
the Mask fixation isn't a new solution for the immobilization of the patient's head and has been used in current practice for long years. This trial is attempting to compare these two technical possibilities of head fixation by mask or by stereotaxic frame. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Brain Metastases
- What is being tested?
- GammaKnifePerfexion®, GammaKnifeIcon® and Efficast®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2016to 21 Mar 2018
- Phase
- Interventional
- 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
Who may be able to join
- Subject bearing of one to five intellectual metastases of lung origin at the time of the indication of the radiosurgery
- Subject requiring a radiosurgical treatment with LGK
Who cannot join
- Subject having hurts of the brainstem or para-optics
- Pregnant women or in feeding period
- Subject having received previously a whole brain radiotherapy
Trial locations and contacts
1 site in 1 country.
About this study
the Mask fixation isn't a new solution for the immobilization of the patient's head and has been used in current practice for long years.
This trial is attempting to compare these two technical possibilities of head fixation by mask or by stereotaxic frame. The primary goal is to evaluate the comfort for the patient and specifically for each step of the procedure. It will also evaluate other parameters such as the effectiveness of these two strategies and tolerance.The expected benefit is an improvement of the comfort for the patients.
- Conditions
- Lung Cancer, Brain Metastases
- Being tested
- GammaKnifePerfexion®, GammaKnifeIcon®, Efficast®, MRI
- Medical subject headings
- Lung Neoplasms, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GammaKnifePerfexion®Device
neurosurgery
GammaKnifeIcon®Device
neurosurgery
Efficast®Device
Thermoformed mask
MRIDevice
| Study group | Role | What they receive |
|---|---|---|
| Group treated by radiosurgery with stereotaxic frame | Active comparator | Subjects will receive a radiosurgery during a brief hospitalization by LeksellGammaKnifePerfexion® (LGKP) Receives: Device: GammaKnifePerfexion®; Device: MRI |
| Group treated by radiosurgery with the thermoformed mask | Experimental | Subjects will receive a radiosurgery with thermoformed mask during a brief hospitalization by GammaKnifeICON® (GKI) with Efficast® Receives: Device: GammaKnifeIcon®; Device: Efficast®; Device: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of pain during the hospitalization (3 days)
Questionary (numeric pain intensity scale)
Measured: 12 months
Secondary outcomes (3)
Evaluation of tumor control at 3 months
No increase of volume greater than 50% on the MRI
Measured: 12 months
Evaluation of tumor control at 6 months
No increase of volume greater than 50% on the MRI
Measured: 12 months
Occurrence of clinical side effects
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2016 (estimated)
- Study startFeb 2016
- Primary completion27 Jul 2017
- Study completion21 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- DESALBRES, Study director, ASSISTANCE PUBLIQUE HÔPITAUX DE MARSEILLE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02732769
- Sponsor's protocol ID
- 2015-40
- Other IDs
- 2015-A01673-46
- Acronym
- Mask
- Status last verified
- Apr 2016
- First submitted
- 30 Mar 2016
- Last updated
- 3 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Treatment of Intellectual Metastases by Radiosurgery Gamma Knife by Means of a Support System by Mask.
- ClinicalTrials.gov ID
- NCT02732769
- Acronym / sponsor ID
- Mask / 2015-40
- Conditions
- Lung Cancer, Brain Metastases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- 27 Jul 2017 (actual)
- Study completion
- 21 Mar 2018 (actual)
- First posted
- 11 Apr 2016 (estimated)
- 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 Mask fixation isn't a new solution for the immobilization of the patient's head and has been used in current practice for long years.
This trial is attempting to compare these two technical possibilities of head fixation by mask or by stereotaxic frame. The primary goal is to evaluate the comfort for the patient and specifically for each step of the procedure. It will also evaluate other parameters such as the effectiveness of these two strategies and tolerance.The expected benefit is an improvement of the comfort for the patients.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group treated by radiosurgery with stereotaxic frame | Active comparator | Device: GammaKnifePerfexion®, Device: MRISubjects will receive a radiosurgery during a brief hospitalization by LeksellGammaKnifePerfexion® (LGKP) |
| Group treated by radiosurgery with the thermoformed mask | Experimental | Device: GammaKnifeIcon®, Device: Efficast®, Device: MRISubjects will receive a radiosurgery with thermoformed mask during a brief hospitalization by GammaKnifeICON® (GKI) with Efficast® |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject bearing of one to five intellectual metastases of lung origin at the time of the indication of the radiosurgery
- Subject requiring a radiosurgical treatment with LGK
Key exclusion criteria (3 listed)
- Subject having hurts of the brainstem or para-optics
- Pregnant women or in feeding period
- Subject having received previously a whole brain radiotherapy
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 |
|---|---|---|
| GammaKnifePerfexion®neurosurgery | Device | Group treated by radiosurgery with stereotaxic frame |
| GammaKnifeIcon®neurosurgery | Device | Group treated by radiosurgery with the thermoformed mask |
| Efficast®Thermoformed mask | Device | Group treated by radiosurgery with the thermoformed mask |
| MRI | Device | Group treated by radiosurgery with stereotaxic frame, Group treated by radiosurgery with the thermoformed mask |
Primary outcome
Evaluation of pain during the hospitalization (3 days)
Time frame: 12 months
Questionary (numeric pain intensity scale)
3 secondary outcomes
Evaluation of tumor control at 3 months
Time frame: 12 months
Evaluation of tumor control at 6 months
Time frame: 12 months
Occurrence of clinical side effects
Time frame: 12 months
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 3 Oct 2018.
- 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.
DESALBRES study director
ASSISTANCE PUBLIQUE HÔPITAUX DE MARSEILLE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GammaKnifePerfexion®, GammaKnifeIcon® and Efficast® in people with Lung Cancer and Brain Metastases, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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 2 inclusion and 3 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 3 Oct 2018. 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 France. 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?
Evaluation of pain during the hospitalization (3 days) (time frame: 12 months). 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 3 Oct 2018.