Clinical trial · Interventional
Study Comparing Neoadjuvant Versus Adjuvant Stereotactic Radiotherapy of Brain Metastases
Prospective, Randomized, Multicenter Study Comparing the Efficacy and Tolerance of Neoadjuvant Versus Adjuvant Stereotactic Radiotherapy in the Management of Brain Metastases
NCT07437820CI-TRIAL-00123782NeoSRSnot yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Metastases, Adult | Brain Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Excision surgery | Procedure | — | UNRESOLVED |
| stereotactic radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Neoadjuvant stereotactic radiotherapy
- description
- 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.
- interventionNames
- Radiation: stereotactic radiotherapy
- Procedure: Excision surgery
- type
- ACTIVE_COMPARATOR
- label
- Control group : adjuvant stereotactic radiotherapy
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.