NCT07437820 - Study Comparing Neoadjuvant Versus Adjuvant Stereotactic Radiotherapy of Brain Metastases | Crick

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).

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

68

Conditions

Brain Metastases, Adult

Interventions

stereotactic radiotherapyRADIATION

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

Excision surgeryPROCEDURE

Brain metastasis removal surgery

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hôpital Privé Clairval

Marseille, France

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 24 months

Central Contacts

Philippe METELLUS, MD

CONTACT

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