Quality of LifeOPTMETACERNCT04358666
Evaluation of the Best Treatment in Terms of Quality of Life for Patients Having a Brain Metastasis
A study testing surgery and focal radiosurgery of the surgical bed in people with Quality of Life and Brain Metastases, run by University Hospital, Caen at 1 site in France.
Trial summary
Main Goal : evaluation of quality of life for patient having a brain metastasis and allowed to have either surgery and radiosurgery of the surgical site or only hypofractionned radiosurgery on the lesion. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Quality of Life, Brain Metastases
- What is being tested?
- surgery and focal radiosurgery of the surgical bed
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 6 Mar 2020to 30 Mar 2024
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- eligible for both treatments options OMS status <3 primary cancer with no evolution brain metastasis < 3cm ou giving symtoms patient with informed consent patient affilated to french social security
Who cannot join
- OMS > 3 More than 3 brain metastasis brain metastasis already treated with hypofractionned radiosurgery
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU CAEN
Caen, 14000
Evelyne Emery, MD PhD, +33 2064605, emery-e@chu-caen.fr
jean jacques Dutheil, PhD, +33 231065351, dutheil-jj@chu-caen.fr
About this study
Main Goal : evaluation of quality of life for patient having a brain metastasis and allowed to have either surgery and radiosurgery of the surgical site or only hypofractionned radiosurgery on the lesion.
second objectives : evaluation of the local control of the disease evaluation of the overall survival interval without progression evaluation of the medico economic performance of each treatment protocol neuro cognitive evaluation at the end of the protocol
Read the detailed description
A patient with a brain metastasis may have the choice between surgery and focal radiosurgery of the surgical site and only hypofractionned radiosurgery on the lesion.
No previous study has focused on quality of life regarding these two treatments options.
- Conditions
- Quality of Life, Brain Metastases
- Being tested
- surgery and focal radiosurgery of the surgical bed
- Keywords
- brain metastasis, best treatment, quality of life, surgery+radiosurgery, hypofractionned radiosurgery
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgery and focal radiosurgery of the surgical bedProcedure or surgery
Also called hypofractionned radiosurgery of the lesion
hypofractionned radiosurgery of the lesion
| Study group | Role | What they receive |
|---|---|---|
| surgery and focal radiosurgery of the surgical site | Active comparator | Not described Receives: Procedure: surgery and focal radiosurgery of the surgical bed |
| hypofractionned radiosurgery | Active comparator | Not described Receives: Procedure: surgery and focal radiosurgery of the surgical bed |
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of life EORTC QLQ C30
score European Organisation for Research and Treatment of Cancer Quality Life Quotation C30
Measured: change between baseline and 6 month
Secondary outcomes (5)
local control of the desease
Measured: baseline up to 24 month
survival without progression
Measured: 24 month
overall survival
Measured: 24 month
medico economic evaluation
cost-utility analysis
Measured: 24 month
neuro cognitive evaluation
BOSTON NAMING TEST
Measured: 12 and 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start6 Mar 2020
- Primary completion30 Mar 2022 (estimated)
- Study completion30 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomization between surgery and focal radiosurgery of the surgical site and hypofractionned radiosurgery of the tumor
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04358666
- Sponsor's protocol ID
- 19-086
- Acronym
- OPTMETACER
- Status last verified
- Mar 2020
- First submitted
- 31 Mar 2020
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Best Treatment in Terms of Quality of Life for Patients Having a Brain Metastasis
- ClinicalTrials.gov ID
- NCT04358666
- Acronym / sponsor ID
- OPTMETACER / 19-086
- Conditions
- Quality of Life, Brain Metastases
- Keywords
- brain metastasis, best treatment, quality of life, surgery+radiosurgery, hypofractionned radiosurgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 6 Mar 2020 (actual)
- Primary completion
- 30 Mar 2022 (estimated)
- Study completion
- 30 Mar 2024 (estimated)
- First posted
- 24 Apr 2020 (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.
Main Goal : evaluation of quality of life for patient having a brain metastasis and allowed to have either surgery and radiosurgery of the surgical site or only hypofractionned radiosurgery on the lesion.
second objectives : evaluation of the local control of the disease evaluation of the overall survival interval without progression evaluation of the medico economic performance of each treatment protocol neuro cognitive evaluation at the end of the protocol
Detailed description
A patient with a brain metastasis may have the choice between surgery and focal radiosurgery of the surgical site and only hypofractionned radiosurgery on the lesion.
No previous study has focused on quality of life regarding these two treatments options.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- randomization between surgery and focal radiosurgery of the surgical site and hypofractionned radiosurgery of the tumor
| Arm | Type | Receives |
|---|---|---|
| surgery and focal radiosurgery of the surgical site | Active comparator | Procedure: surgery and focal radiosurgery of the surgical bed |
| hypofractionned radiosurgery | Active comparator | Procedure: surgery and focal radiosurgery of the surgical bed |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- eligible for both treatments options OMS status <3 primary cancer with no evolution brain metastasis < 3cm ou giving symtoms patient with informed consent patient affilated to french social security
Key exclusion criteria (1 listed)
- OMS > 3 More than 3 brain metastasis brain metastasis already treated with hypofractionned radiosurgery
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 |
|---|---|---|
| surgery and focal radiosurgery of the surgical bedAlso: hypofractionned radiosurgery of the lesionhypofractionned radiosurgery of the lesion | Procedure or surgery | hypofractionned radiosurgery, surgery and focal radiosurgery of the surgical site |
Primary outcome
quality of life EORTC QLQ C30
Time frame: change between baseline and 6 month
score European Organisation for Research and Treatment of Cancer Quality Life Quotation C30
5 secondary outcomes
local control of the desease
Time frame: baseline up to 24 month
survival without progression
Time frame: 24 month
overall survival
Time frame: 24 month
medico economic evaluation
Time frame: 24 month
neuro cognitive evaluation
Time frame: 12 and 24 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Quality of Life
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Study of a Support Program for Quality of Life in Chinese Cancer Patients and Survivors
Cancer, Survivorship
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Not yet recruitingPhase 2
Alberta Cancer Exercise Dose in Colorectal Cancer
Cancer, Colorectal Cancer
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing surgery and focal radiosurgery of the surgical bed in people with Quality of Life and Brain Metastases, run by University Hospital, Caen 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 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: status not confirmed, as of the sponsor's last update on 24 Apr 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quality of life EORTC QLQ C30 (time frame: change between baseline and 6 month). 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 24 Apr 2020.