Study Comparing Neoadjuvant Versus Adjuvant Stereotactic Radiotherapy of Brain Metastases (NeoSRS)

Prospective, Randomized, Multicenter Study Comparing the Efficacy and Tolerance of Neoadjuvant Versus Adjuvant Stereotactic Radiotherapy in the Management of Brain Metastases

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Brain Metastases, Adult
• Intervention / Treatment: Radiation: stereotactic radiotherapy; Procedure: Excision surgery

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).

• Study Type: Interventional
• Enrollment (Estimated): 68
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Philippe METELLUS, MD; Phone Number: +33 04 91 17 14 83; Email: philippe.metellus@outlook.fr

Study Locations

• France
  • Marseille, France, 13273
    • Hopital Prive Clairval
    • Contact: Philippe METELLUS, MD; Phone Number: +33 04 91 17 14 83; Email: philippe.metellus@outlook.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Neoadjuvant stereotactic radiotherapy; Innovative treatment with neoadjuvant stereotactic radiotherapy, with the protocol requiring SRS to be performed 4 days ± 1 day before surgery to remove the target brain metastasis. Neuronavigation magnetic resonance imaging and a tracking scan, necessary for contouring the lesions and creating the treatment mask, will be performed within 7 days prior to the start of radiotherapy. These examinations are essential regardless of the type of stereotactic radiotherapy (adjuvant or neoadjuvant) and are routinely performed for lesion contouring.	Radiation: stereotactic radiotherapy; Stereotactic radiotherapy is part of the standard treatment for brain metastases.; Procedure: Excision surgery; Brain metastasis removal surgery
Active Comparator: Control group : adjuvant stereotactic radiotherapy; Standard care in accordance with the gold standard, with stereotactic radiotherapy performed as an adjunct to the surgical bed of the targeted lesion, i.e., 4 to 6 weeks after surgery. Neuronavigation magnetic resonance imaging and a tracking scan, necessary for contouring the lesions and creating the treatment mask, will be performed within 7 days prior to the start of radiotherapy.	Radiation: stereotactic radiotherapy; Stereotactic radiotherapy is part of the standard treatment for brain metastases.; Procedure: Excision surgery; Brain metastasis removal surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local control rate of the target lesion	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.	6 months
Local control rate of the target lesion	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.	12 months
Local control rate of the target lesion	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.	24 months

Collaborators and Investigators

• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Collaborators: Euraxi Pharma

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): June 30, 2030

Study Registration Dates

• First Submitted: February 23, 2026
• First Submitted That Met QC Criteria: February 23, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Site; Neoplasms; Nervous System Neoplasms; Central Nervous System Neoplasms; Brain Neoplasms; Investigative Techniques; Therapeutics; Surgical Procedures, Operative; Radiotherapy; Stereotaxic Techniques; Neurosurgical Procedures; Radiosurgery
• Other Study ID Numbers: 2025-A02642-47

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No