NCT02565433

Brief Summary

The aim of the study is to assess prospectively the impact of radiosurgery on the quality of life in patients with brain metastases.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 5, 2014

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 19, 2015

Completed
5 months until next milestone

First Posted

Study publicly available on registry

October 1, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

3.9 years

First QC Date

May 19, 2015

Last Update Submit

March 12, 2026

Conditions

Neoplasm Metastases

Keywords

brain metastasesGamma KnifeRadiosurgeryQuality of Life

Outcome Measures

Primary Outcomes (1)

  • 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 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

    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

    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

    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

  • +1 more secondary outcomes

Study Arms (1)

questionnaire administration

EXPERIMENTAL

Quality of life questionnaires administration (EORTC QLQ C30 and BN20 / IADL / HADS / MoCa Edmonton Symptom Assessment Scale)

Other: questionnaire administration

Interventions

questionnaire administrationOTHER

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

Also known as: survey administration
questionnaire administration

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Lille - Hôpital Salengro

Lille, 59037, France

Location

MeSH Terms

Conditions

Neoplasm MetastasisBrain Neoplasms

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and SymptomsCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Emilie Le Rhun, MD

    Centre Oscar Lambret

    PRINCIPAL INVESTIGATOR

  • Franck Bonnetain, MD

    CHRU de Besançon

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2015

First Posted

October 1, 2015

Study Start

February 5, 2014

Primary Completion

January 1, 2018

Study Completion

June 1, 2018

Last Updated

March 16, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)