Status:
COMPLETED
Preoperative Stereotactic Radiosurgery for Brain Metastases
Lead Sponsor:
Centre Jean Perrin
Collaborating Sponsors:
Groupement Interrégional de Recherche Clinique et d'Innovation (AURA)
Conditions:
Brain Metastases
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 metastas...
Eligibility Criteria
Inclusion
- ≤ 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
- 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
Key Trial Info
Start Date :
February 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 25 2025
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04503772
Start Date
February 4 2021
End Date
November 25 2025
Last Update
December 4 2025
Active Locations (8)
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1
Centre Jean PERRIN
Clermont-Ferrand, Puy-de-Dôme, France, 63800
2
CHU Grenoble Alpes
Grenoble, France, 38700
3
Hospices Civils de Lyon
Lyon, France, 69002
4
Centre Léon BÉRARD
Lyon, France, 69373