Preoperative Stereotactic Radiosurgery for Brain Metastases

Phase II Study to Assess Preoperative Hypofractionated Stereotactic Radiotherapy of Brain Metastases

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

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