- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02565433
Prospective Assessment of Quality of Life in Patients Treated by Radiosurgery for Brain Metastases (PRAMECE-1302) (PRAMECE-1302)
October 19, 2018 updated by: Centre Oscar Lambret
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
52
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Lille, France, 59037
- CHRU de Lille - Hôpital Salengro
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: questionnaire administration
Quality of life questionnaires administration (EORTC QLQ C30 and BN20 / IADL / HADS / MoCa Edmonton Symptom Assessment Scale)
|
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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
QLQ C30, BN20 (quality of life), IADL (autonomy), HADS (anxiety-depression), MoCA (cognition), ESAS (quality of life), Performance status (OMS)
|
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
|
QLQ C30, BN20 (quality of life), IADL (autonomy), HADS (anxiety-depression), MoCA (cognition)
|
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
|
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) |
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
|
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
|
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
|
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
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Emilie Le Rhun, MD, Centre Oscar Lambret
- Study Director: Franck Bonnetain, MD, CHRU De Besancon
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2013
Primary Completion (Actual)
January 1, 2018
Study Completion (Actual)
June 1, 2018
Study Registration Dates
First Submitted
May 19, 2015
First Submitted That Met QC Criteria
September 29, 2015
First Posted (Estimate)
October 1, 2015
Study Record Updates
Last Update Posted (Actual)
October 22, 2018
Last Update Submitted That Met QC Criteria
October 19, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRAMECE-1302
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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