Clinical trial · Interventional
Preoperative Stereotactic Radiosurgery for Brain Metastases
Phase II Study to Assess Preoperative Hypofractionated Stereotactic Radiotherapy of Brain Metastases
NCT04503772CI-TRIAL-00098396STEPcompletedPhase 2ClinicalTrials.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)
STEP is a French multicentre, prospective, non-randomized, phase II study designed to assess 6-months local control after pre-operative stereotactic radiosurgery (SRS) for patients with brain metastases
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 | Brain Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Preoperative SRS | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental arm (all patients)
- description
- Patients will receive preoperative hypofractionated stereotactic radiosurgery (SRS). According to the association of french-speaking neuro-oncologists (ANOCEF) recommendations, total dose and fractionation will be 33 Gy in 3 fractions at the isocenter, 23.1 Gy in envelope (70% isodose), i.e. 30 Gy in growth tumor volume (GTV) envelope.) Surgery will take place within 3 days of the preoperative SRS.
- interventionNames
- Procedure: Preoperative SRS
Primary outcomes (1)
- measure
- Evaluation of 6-months local control rate after preoperative SRS
- timeFrame
- 6 months after preoperative SRS (M6)
- description
- Local recurrence is defined as the onset or progression of nodular contrast grafting within the resection cavity according to the Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria.
Secondary outcomes (9)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * ≤ 4 distinct brain metastases, one with surgical indication * Diagnosis of primary histologically proven breast, digestive or non-small cells lung cancer * ≤ 5 cm larger diameter * Karnofsky performance status ≥ 70 * No contraindication for MRI * Possibility for the patient to be treat with both surgery and stereotactic radiotherapy * ≥ 18 years old * Estimated overall survival ≥ 6 months according to diagnosis specific - graded prognostic assessment (DS GPA) * Written inform consent signed * Affiliation to the French social security system * For women of childbearing age including those on luteinizing hormone-releasing hormone (LH-RH) agonists for ovarian suppression: inclusion negative serum pregnancy test (≤ 7 days prior to the start of preoperative stereotactic radiosurgery (SRS). Exclusion Criteria: * Lymphoma, leukaemia, multiple myeloma, germinal tumours or cerebral primary cancer * Metastases from small-cells lung cancer, kidney cancer, melanoma or sarcoma * Mass effect with deflection ≥ 5 mm from median line or hydrocephaly or compression 4th ventricle, patient neurologically unstable, need for emergency decompressive surgery * \> 4 brain metastases * Contraindication to anaesthesia, MRI or gadolinium injection * Proximity of the tumour with organs at risk which do not allow the prescribed dose to be reached in the envelope * Pregnant or breastfeeding woman * Anti vascular endothelial growth factor (VEGF) within 6 weeks before treatment * Documented leptomeningeal injury * History of irradiation of the encephalon in toto * History of stereotactic radiotherapy on metastasis to be operated on * Non-candidate patient for surgery * Surgical delay \> 3 days compared to stereotactic radiotherapy * Estimated survival \< 6 months by DS GPA * Patient under guardianship or curators * Psychological disorder (cognitive disorders, mental alertness, etc.) or social (deprivation of liberty by judicial or administrative decision) or geographical reasons that may compromise medical monitoring of the trial or compliance with treatment * Woman of childbearing age without effective contraception * Patient participating in another intervention study within 4 weeks prior to inclusion
References
Publications (1)
- RESULTGinzac A, Dupic G, Brun L, Molnar I, Casile M, Durando X, Verrelle P, Lemaire JJ, Khalil T, Biau J. Preoperative stereotactic radiosurgery for brain metastases: the STEP study protocol for a multicentre, prospective, phase-II trial. BMC Cancer. 2021 Jul 28;21(1):864. doi: 10.1186/s12885-021-08602-0. PMID 34320940