Preoperative Stereotactic Radiosurgery for Brain Metastases

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04503772
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Centre Jean Perrin
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Lucie BRUN, MD
Principal Investigator Affiliation	Centre Jean Perrin
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	France
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Brain Metastases
Study Website:	View Trial Website

Arms & Interventions

Arms

Experimental: Experimental arm (all patients)

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.

Interventions

Procedure: - Preoperative SRS

Patient will be treat with preoperative SRS and then surgery for brain metastases is realized within 3 days.

Contact a Trial Team

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