Neoplasm MetastasesPRAMECENCT02565433
Prospective Assessment of Quality of Life in Patients Treated by Radiosurgery for Brain Metastases (PRAMECE-1302)
A study testing questionnaire administration in people with Neoplasm Metastases, run by Centre Oscar Lambret at 1 site in France.
Trial summary
The aim of the study is to assess prospectively the impact of radiosurgery on the quality of life in patients with brain metastases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasm Metastases
- What is being tested?
- questionnaire administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteFrance
- Study dates
- 5 Feb 2014to Jun 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
- Patient with newly diagnosed brain metastases
- Patient with cancer regardless of the type of primary cancer, with anatomopathological proof
- At least, one measurable lesion ≥ 10 mm on the MRI T1 gadolinium sequences
- Number of brain metastases lower or equal to 5
- Indication of radiosurgery treatment
- Age ≥ 18 years old
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- ECOG-PS 0-2
- Expected survival > 3 months
- Ability to complete self-administered questionnaires. If the patient has a motor disability (hemibody deficit) that does not allow to complete himself the questionnaires, these will be read by a CRA of the Neurosurgery department who will outline the questions without making any comment.
- A non-opposition form must have been completed by the patient
Who cannot join
- Previous cancer (< 5 years) except of carcinoma of cervix uteri, basal cell or squamous cell skin carcinoma adequately treated
- Previous brain radiotherapy
- Neurological pathology with cognitive disorders existing before the study
- Having a contraindication for MRI
- Associated leptomeningeal disease
- Patients having another severe or uncontrolled pathology which could compromise the participation at the study (such as infection, cardiovascular, digestive, renal or pulmonary disease)
- Pregnant or breastfeeding woman. The women must not breastfeed for at least 6 months
- Impossibility to submit to the medical examinations of the study due to geographic, social or mental reasons
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Assessment of Quality of Life in Patients Treated by Radiosurgery for Brain Metastases
The aim of the study is to assess prospectively the impact of radiosurgery on the quality of life in patients with brain metastases.
Read the detailed description
The patients who meet the selection criteria and who have accepted to participate at the study will answer different questionnaires of the study before radiosurgery and at 3, 6, 9 and 12 months after the treatment of brain metastases. Baseline examinations will be done before receiving the treatment during the hospitalisation for the Gamma Knife treatment, and then they will be repeated at the evaluation visits which are classically done every 3 months. MRI's will also be performed every 3 months. In this way, no additional travel or MRI will be carried out as part of the study.
- Conditions
- Neoplasm Metastases
- Being tested
- questionnaire administration
- Keywords
- brain metastases, Gamma Knife, Radiosurgery, Quality of Life
- Medical subject headings
- Neoplasm Metastasis, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaire administrationOther
Also called survey administration
Within 15 days before radiosurgery and then at 3, 6, 9, 12 months after radiosurgery, the patients who have accepted to participate will have to complete these questionnaires : QLQC30, BN20, IADL, HADS, MoCa, Edmonton Symptom Assessment Scale
| Study group | Role | What they receive |
|---|---|---|
| questionnaire administration | Experimental | Quality of life questionnaires administration (EORTC QLQ C30 and BN20 / IADL / HADS / MoCa Edmonton Symptom Assessment Scale) Receives: Other: questionnaire administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact at 6 months of the radiosurgery based on the evaluation of 4 criteria of the QLQ C30 questionnaire
The 4 criteria are the perceived overall state, health, physical functioning, cognitive functioning and tiredness
Measured: 6 months
Secondary outcomes (6)
Comparison of the scores obtained on the scales, questionnaires and Performance status at baseline and every 3 months (until 12 months) after Gamma Knife treatment
QLQ C30, BN20 (quality of life), IADL (autonomy), HADS (anxiety-depression), MoCA (cognition), ESAS (quality of life), Performance status (OMS)
Measured: 1 year
Comparison of the scores obtained on the scales and questionnaires according to the type of primary cancer at baseline and every 3 months (until 12 months) after Gamma Knife treatment
QLQ C30, BN20 (quality of life), IADL (autonomy), HADS (anxiety-depression), MoCA (cognition)
Measured: 1 year
Comparison of the scores obtained on different scales according to the type of associated treatments at baseline and every 3 months (until 12 months) after Gamma Knife treatment
The type of associated treatments are: chemotherapy, targeted therapy, corticoids, anti-epileptics, psychotropic drugs.
The different scales are QLQ C30, BN20 (quality of life), IADL (autonomy), HADS (anxiety-depression), ESAS (quality of life) and MoCA (cognition)
Measured: 1 year
Correlation between the scores obtained on the different scales at the baseline and the progression-free survival / overall survival
Measured: 1 year
Correlation between the scores obtained on the scales QLQ C30, BN20 (quality of life), IADL (autonomy), HADS (anxiety-depression), MoCA (cognition), ESAS (quality of life) at baseline and those obtained at 3, 6, 9, 12 months
Measured: 1 year
Correlation between the scores obtained on the scales during the study and the clinical neurological response at baseline and every 3 monts until 12 months after Gamma Knife treatment
The correlation will take into account the evolution of the systemic disease and the volumetric tumor response. Volumetric tumor responses will be calculated on the MRI's
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2015 (estimated)
- Study start5 Feb 2014
- Primary completionJan 2018
- Study completionJun 2018
Why it stopped: lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasm 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Oscar Lambret
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Besancon
- Responsible party
- Sponsor
- Investigators
- Emilie Le Rhun, MD, Principal investigator, Centre Oscar LambretFranck Bonnetain, MD, Study director, CHRU de Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02565433
- Sponsor's protocol ID
- PRAMECE-1302
- Other IDs
- 22013-A00192-43
- Acronym
- PRAMECE
- Status last verified
- Mar 2026
- First submitted
- 19 May 2015
- Last updated
- 16 Mar 2026
- 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 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Assessment of Quality of Life in Patients Treated by Radiosurgery for Brain Metastases
- ClinicalTrials.gov ID
- NCT02565433
- Acronym / sponsor ID
- PRAMECE / PRAMECE-1302
- Conditions
- Neoplasm Metastases
- Keywords
- brain metastases, Gamma Knife, Radiosurgery, Quality of Life
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of recruitment
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Centre Oscar LambretUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Besancon
- Study start
- 5 Feb 2014 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 1 Oct 2015 (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 aim of the study is to assess prospectively the impact of radiosurgery on the quality of life in patients with brain metastases.
Detailed description
The patients who meet the selection criteria and who have accepted to participate at the study will answer different questionnaires of the study before radiosurgery and at 3, 6, 9 and 12 months after the treatment of brain metastases. Baseline examinations will be done before receiving the treatment during the hospitalisation for the Gamma Knife treatment, and then they will be repeated at the evaluation visits which are classically done every 3 months. MRI's will also be performed every 3 months. In this way, no additional travel or MRI will be carried out as part of the study.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| questionnaire administration | Experimental | Other: questionnaire administrationQuality of life questionnaires administration (EORTC QLQ C30 and BN20 / IADL / HADS / MoCa Edmonton Symptom Assessment Scale) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patient with newly diagnosed brain metastases
- Patient with cancer regardless of the type of primary cancer, with anatomopathological proof
- At least, one measurable lesion ≥ 10 mm on the MRI T1 gadolinium sequences
- Number of brain metastases lower or equal to 5
- Indication of radiosurgery treatment
Key exclusion criteria (8 listed)
- Previous cancer (< 5 years) except of carcinoma of cervix uteri, basal cell or squamous cell skin carcinoma adequately treated
- Previous brain radiotherapy
- Neurological pathology with cognitive disorders existing before the study
- Having a contraindication for MRI
- Associated leptomeningeal disease
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 |
|---|---|---|
| questionnaire administrationAlso: survey administrationWithin 15 days before radiosurgery and then at 3, 6, 9, 12 months after radiosurgery, the patients who have accepted to participate will have to complete these questionnaires : QLQC30, BN20, IADL, HADS, MoCa, Edmonton Symptom Assessment Scale | Other | questionnaire administration |
Primary outcome
Impact at 6 months of the radiosurgery based on the evaluation of 4 criteria of the QLQ C30 questionnaire
Time frame: 6 months
The 4 criteria are the perceived overall state, health, physical functioning, cognitive functioning and tiredness
6 secondary outcomes
Comparison of the scores obtained on the scales, questionnaires and Performance status at baseline and every 3 months (until 12 months) after Gamma Knife treatment
Time frame: 1 year
Comparison of the scores obtained on the scales and questionnaires according to the type of primary cancer at baseline and every 3 months (until 12 months) after Gamma Knife treatment
Time frame: 1 year
Comparison of the scores obtained on different scales according to the type of associated treatments at baseline and every 3 months (until 12 months) after Gamma Knife treatment
Time frame: 1 year
Correlation between the scores obtained on the different scales at the baseline and the progression-free survival / overall survival
Time frame: 1 year
Correlation between the scores obtained on the scales QLQ C30, BN20 (quality of life), IADL (autonomy), HADS (anxiety-depression), MoCA (cognition), ESAS (quality of life) at baseline and those obtained at 3, 6, 9, 12 months
Time frame: 1 year
Correlation between the scores obtained on the scales during the study and the clinical neurological response at baseline and every 3 monts until 12 months after Gamma Knife treatment
Time frame: 1 year
Results and safety
The study was stopped early (reason given: lack of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- 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.
Emilie Le Rhun, MD principal investigator
Centre Oscar Lambret
Franck Bonnetain, MD study director
CHRU de Besançon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing questionnaire administration in people with Neoplasm Metastases, run by Centre Oscar Lambret 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 10 inclusion and 8 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: stopped early, as of the sponsor's last update on 16 Mar 2026. 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 was stopped early (reason given: lack of recruitment). 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?
Impact at 6 months of the radiosurgery based on the evaluation of 4 criteria of the QLQ C30 questionnaire (time frame: 6 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 16 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.