NCT04397978

Brief Summary

To observe the quality of life (QOL) and to report on toxicity and outcome parameters after the (repeated) use of local ablative therapy (LAT) i.e. stereotactic radiotherapy (SRT) for patients with multiple (4-10) brain metastases

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

First Submitted

Initial submission to the registry

May 11, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 21, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

October 10, 2020

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

July 1, 2024

Status Verified

June 1, 2024

Enrollment Period

4.6 years

First QC Date

May 11, 2020

Last Update Submit

June 28, 2024

Conditions

Brain Metastases, Adult

Keywords

Stereotactic radiotherapyBrain metastasesMultiple (4-10)

Outcome Measures

Primary Outcomes (3)

  • Quality of life

    Measured by the EQ-5D-5L questionnaire

    From baseline to 3 month after radiotherapy

  • Quality of life

    Measured by the QLQ-BN20 questionnaire

    From baseline to 3 month after radiotherapy

  • Quality of life

    Measured by the PRO-CTCAE

    From baseline to 3 month after radiotherapy

Secondary Outcomes (9)

  • Quality of life

    From baseline to 1,6,9 and 12 month (+q3month) after radiotherapy

  • Quality of life

    From baseline to 1,6,9 and 12 month (+q3month) after radiotherapy

  • Quality of life

    From baseline to 1,6,9 and 12 month (+q3month) after radiotherapy

  • Local control

    Time from SRT until local progression or death whichever comes first, up to 3 years after LAT

  • Survival

    Time from SRT until the occurrence of new brain metastases or death whichever comes first, up to 3 years after LAT

  • +4 more secondary outcomes

Interventions

Stereotactic radiotherapyRADIATION

Local ablative therapy with SRT

Also known as: SRT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients with an established diagnosis on dedicated brain magnetic resonance (MRI) of 4-10 brain metastases (BM) of any solid tumor with an estimated life expectancy of \>3 months or a disease specific grade prognostic index (DS-GPA) of ≥ 1.5.

You may qualify if:

  • Male or female, ≥ 18 years of age
  • Maximal lesion diameter of single gross tumor volume (GTV) of 3 cm
  • Maximal cumulative GTV (+CTV for cavity) of 30cm3
  • Karnofsky performance status ≥ 70
  • DS-GPA or expected overall survival (if no DS-GPA applicable) of ≥ 1.5 or \>3 months respectively.
  • Any solid primary tumour. Lymphoma, germ cell tumor, small cell lung carcinoma and multiple myeloma are excluded.
  • Ability to provide written informed consent and to participate in the procedure of the questionnaires.

You may not qualify if:

  • BM not amenable to SRT
  • Previous SRT or surgery on the same lesion
  • Co-morbidities considered clinically precluding the safe use of an MRI examination or SRT
  • Any psychological, sociological or geographical issue potentially hampering compliance with the study
  • Pregnancy
  • Concurrent use of systemic therapy
  • More than 10 BM on planning-MRI
  • Maximum cumulative GTV (+CTV for cavity) of more than 30cm3 on planning-MRI
  • A brainstem metastasis with a PTV of more than 20 cm3
  • Leptomeningeal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZLeuven

Leuven, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Patrick Berkovic, MD

    UZ Leuven

    PRINCIPAL INVESTIGATOR

  • Maarten Lambrecht, PHD

    UZ Leuven

    STUDY CHAIR

  • Eva Oldenburger, MD

    UZ Leuven

    STUDY CHAIR

  • An Nulens

    UZ Leuven

    STUDY CHAIR

  • Lien Smets, BA

    UZ Leuven

    STUDY CHAIR

Central Study Contacts

Patrick Berkovic, MD

CONTACT

+32-16-34-76-00Patrick.berkovic@uzleuven.be

Deveny Vanrusselt, BA

CONTACT

+32-16-34-76-00deveny.vanrusselt@uzleuven.be

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2020

First Posted

May 21, 2020

Study Start

October 10, 2020

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

July 1, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)