Preoperative Stereotactic Radiosurgery for Brain Metastases (STEP)

Centre Jean Perrin

Status and phase: Completed; Phase 2

Conditions: Brain Metastases

Treatments: Procedure: Preoperative SRS

Study type: Interventional

Funder types: Other

Identifiers

NCT04503772

2020-A00403-36

20.06.16-36701 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 1 patient group

Experimental arm (all patients)

Experimental group

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.

Treatment:

Procedure: Preoperative SRS