Study Comparing Neoadjuvant Versus Adjuvant Stereotactic Radiotherapy of Brain Metastases
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: stereotactic radiotherapy, Excision surgery.
- Who it may be relevant to
- Registry conditions: Brain Metastases, Adult. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prospective, Randomized, Multicenter Study Comparing the Efficacy and Tolerance of Neoadjuvant Versus Adjuvant Stereotactic Radiotherapy in the Management of Brain Metastases
Overview
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
- Radiation stereotactic radiotherapy
Stereotactic radiotherapy is part of the standard treatment for brain metastases. - Procedure Excision surgery
Brain metastasis removal surgery
Primary outcome measures
- Local control rate of the target lesion [Time frame: 6 months]
- Local control rate of the target lesion [Time frame: 12 months]
- Local control rate of the target lesion [Time frame: 24 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 1 center
- Hôpital Privé Clairval — Marseille
Identifiers
NCT: NCT07437820 · 2025-A02642-47