Brain Metastases, Adult
Conditions
Brief summary
The purpose of this study is to evaluate the local control rate on the target lesion at 6, 12, and 24 months after treatment with neoadjuvant stereotactic radiotherapy (SRS NEO group) compared to standard care, adjuvant stereotactic radiotherapy (POST OP SRS group).
Detailed description
This is a phase III, prospective, multicenter, randomized, two-group, controlled, open-label interventional study designed to evaluate the efficacy in terms of local progression-free survival of neoadjuvant stereotactic radiotherapy for brain metastases compared with adjuvant stereotactic radiotherapy. The study population is composed of adult patients with 1 to 12 newly diagnosed brain metastases who require surgical treatment for the removal of at least one lesion. The two therapeutic strategies studied in the trial are as follows: * SRS NEO group (experimental group): stereotactic radiotherapy administered as neoadjuvant therapy (4 days ± 1 day before surgery to remove the brain metastasis). * POST OP SRS group (control group): stereotactic radiotherapy performed adjuvantly (4 to 6 weeks after surgery to remove the brain metastasis).
Interventions
RADIATIONstereotactic radiotherapy
Stereotactic radiotherapy is part of the standard treatment for brain metastases.
PROCEDUREExcision surgery
Brain metastasis removal surgery
Sponsors
GCS Ramsay Santé pour l'Enseignement et la Recherche
Euraxi Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Due to the difference in the timing of stereotactic radiotherapy treatment (before or after surgery), blinding of patients or investigators will not be possible; however, magnetic resonance imaging will be analyzed by independent centralized review performed by neuroradiologists.
Intervention model description
Phase III, prospective, multicenter, randomized, two-group, controlled, open-label interventional study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients aged 18 years and older; * Patients with 1 to 12 brain metastases on preoperative MRI, at least one of which (contrast enhancement of at least 1 cm) is accessible for the most complete possible resection (target lesion); * Patients with a Karnofsky performance score of ≥ 70; * Patients able to perform neurocognitive tests without assistance; * Patients who understand the study and agree to attend all visits; * Patients who have signed a written informed consent form; * Affiliation with a social security system.
Exclusion criteria
* Patient who has already been treated with surgery, radiosurgery, and/or radiotherapy for the target brain metastasis; * Medical contraindication to MRI; * Patient with an estimated life expectancy of ≤ 3 months; * Patients participating in another clinical trial, or who are in the exclusion period of another clinical trial; * Patients unable to complete a self-administered questionnaire; * Patients from a vulnerable population.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Local control rate of the target lesion | 6 months | The local control rate of the target lesion will be determined by the percentage of lesions that have recurred locally. Local progression will be defined, for the treated metastatic lesion, by the appearance on follow-up magnetic resonance imaging of contrast enhancement in the surgical cavity, according to the criteria for assessing response in neuro-oncology of brain metastases. |
Countries
France
Contacts
CONTACTPhilippe METELLUS, MD
Outcome results
None listed