Study Comparing Neoadjuvant Versus Adjuvant Stereotactic Radiotherapy of Brain Metastases

NCT07437820 | Not Yet Recruiting

• 1 other identifier: 2025-A02642-47
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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).

Conditions

Brain Metastases, Adult

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Neoadjuvant stereotactic radiotherapy

EXPERIMENTAL

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; Procedure: Excision surgery

Control group : adjuvant stereotactic radiotherapy

ACTIVE COMPARATOR

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; Procedure: Excision surgery

Interventions

stereotactic radiotherapy RADIATION

Stereotactic radiotherapy is part of the standard treatment for brain metastases.

Control group : adjuvant stereotactic radiotherapy; Neoadjuvant stereotactic radiotherapy

Excision surgery PROCEDURE

Brain metastasis removal surgery

Control group : adjuvant stereotactic radiotherapy; Neoadjuvant stereotactic radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 unable to complete a self-administered questionnaire;
• Patients from a vulnerable population.

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead
• Euraxi Pharma: collaborator

Study Sites (1)

Hôpital Privé Clairval

Marseille, 13273, France

Location

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Philippe METELLUS, MD

CONTACT

04 91 17 14 83; philippe.metellus@outlook.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Phase III, prospective, multicenter, randomized, two-group, controlled, open-label interventional study

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: February 27, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): June 30, 2030
• Last Updated: June 15, 2026

Record last verified: 2026-06

Locations

FR (1)