Prospective Assessment of Quality of Life in Patients Treated by Radiosurgery for Brain Metastases (PRAMECE-1302) (PRAMECE)

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: Neoplasm Metastases
• Intervention / Treatment: Other: questionnaire administration

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

Study Locations

• France
  • Lille, France, 59037
    • CHRU de Lille - Hôpital Salengro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

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

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

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)	Other: questionnaire 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; Other Names: survey administration

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	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	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	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	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		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		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	1 year

Collaborators and Investigators

• Sponsor: Centre Oscar Lambret
• Collaborators: Centre Hospitalier Universitaire de Besançon
• Investigators: Principal Investigator: Emilie Le Rhun, MD, Centre Oscar Lambret; Study Director: Franck Bonnetain, MD, CHRU De Besancon

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2014
• 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 (Estimated): October 1, 2015

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Quality of Life; brain metastases; Radiosurgery; Gamma Knife
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pathologic Processes; Neoplasms by Site; Neoplasms; Neoplastic Processes; Nervous System Neoplasms; Central Nervous System Neoplasms; Pathological Conditions, Signs and Symptoms; Neoplasm Metastasis; Brain Neoplasms
• Other Study ID Numbers: PRAMECE-1302; 22013-A00192-43 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO