Preoperative Stereotactic Radiosurgery for Brain Metastases

  • STATUS
    Recruiting
  • End date
    Jul 15, 2023
  • participants needed
    70
  • sponsor
    Centre Jean Perrin
Updated on 15 August 2021
Investigator
Angeline GINZAC
Primary Contact
Centre Hospitalier d'Annecy-Genevois (0.6 mi away) Contact
+7 other location

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 metastases

Details
Condition Brain Metastasis, Brain Metastases
Treatment Preoperative SRS
Clinical Study IdentifierNCT04503772
SponsorCentre Jean Perrin
Last Modified on15 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

distinct brain metastases, one with surgical indication
Diagnosis of primary histologically proven breast, digestive or non-small cells lung cancer
cm larger diameter
Karnofsky performance status 70
No contraindication for MRI
Possibility for the patient to be treat with both surgery and stereotactic radiotherapy
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
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