Stereotactic Radiotherapy for Brain Metastases (CKBrainMeta)

June 20, 2022 updated by: Centre Francois Baclesse, Luxembourg

Stereotactic Radiotherapy for Patients With Brain Metastases

Stereotactic radiotherapy is an innovative treatment enabling to target accurately brain metastases. The aim of this study is to evaluate tumoral response and acute and late toxicity of this treatment.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

110

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

  • Luxembourg
    • SUD
      • Esch-sur-Alzette, SUD, Luxembourg, L-4240
        • Centre Francois Baclesse

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

Sampling Method

Non-Probability Sample

Study Population

Patients with brain metastases

Description

Inclusion Criteria:

  • Situation 1: in case of several cerebral metastases. In this case, the maximum of cerebral metastases is 3, and the maximum diameter of the largest can not exceed 3 cm. The other two ones can not exceed 1 cm or even maximum 2 cm in diameter for one of the two. The same principle will remain valid in the presence of 2 metastases.
  • Situation 2: in the case of a single metastasis, the diameter should be a maximum of 3 cm
  • Situation 3: in case of metastasis supposed to be radioresistant (renal adenocarcinoma, sarcoma, melanoma ...), only a single metastasis of not more than 3 cm in diameter will be accepted. A primary resection followed by radiotherapy will be preferred.
  • Situation 4: In case of localization near a structure at risk (contact with anterior optical pathways, central nuclei or the brainstem or localization in these structures), a maximum number of 3 metastases may be accepted. However, that included in or close to the risk structure can not exceed 2 cm in diameter and the other two, located outside a risk structure will have a diameter not exceeding 1 or even maximum 2 cm.
  • Situation 5: single metastasis of maximum 3 cm in a context of re-irradiation, the whole encephalon having already received the dose of 10 X 3 Gy or its biological equivalent of dose.
  • Signed informed consent

Exclusion Criteria:

  • Impossibility of performing an MRI or a CT-scan of the brain with injection of contrast agent
  • Metastases greater than 3 cm at the start

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Stereotactic radiation
Stereotactic radiation for brain metastases
Radiation: stereotactic radiotherapy
stereotactic radiotherapy for brain metastases

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of tumoral response
Time Frame: 4 weeks after treatment
Evaluation of response using Magnetic resonance imaging (Recist criteria)
4 weeks after treatment
Evaluation of tumoral response
Time Frame: 8 weeks after treatment
Evaluation of response using Magnetic resonance imaging (Recist criteria)
8 weeks after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of toxicity
Time Frame: 1, 3, 6, 9, 12, 15 months after treatment
Evaluation of toxicity using CTCAE v4.0
1, 3, 6, 9, 12, 15 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Francois Baclesse, Luxembourg

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

October 1, 2014

Primary Completion (ACTUAL)

October 1, 2019

Study Completion (ANTICIPATED)

December 1, 2022

Study Registration Dates

First Submitted

September 7, 2017

First Submitted That Met QC Criteria

September 15, 2017

First Posted (ACTUAL)

September 18, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 22, 2022

Last Update Submitted That Met QC Criteria

June 20, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CYM6 Brain metastases CFB 1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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