About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

stereotactic radiotherapy
Radiation
Stereotactic radiotherapy is part of the standard treatment for brain metastases.
Excision surgery
Procedure/Surgery
Brain metastasis removal surgery

Treatment groups

68 Participants

are divided into 2 treatment groups

Group A: Neoadjuvant stereotactic radiotherapyExperimental treatment 2 interventions

Group B: Control group : adjuvant stereotactic radiotherapyActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

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

2

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

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.

Time frame

24 months

Study Comparing Neoadjuvant Versus Adjuvant Stereotactic Radiotherapy of Brain Metastases

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts