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

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Centre Jean PERRIN, Clermont-Ferrand, Puy-de-Dôme, France

Status

Recruiting

Address

Centre Jean PERRIN

Clermont-Ferrand, Puy-de-Dôme, 63800

Site Contact

Lucie BRUN, MD

[email protected]

0463663337

CHU Grenoble Alpes, Grenoble, France

Status

Recruiting

Address

CHU Grenoble Alpes

Grenoble, , 38700

Site Contact

Andréa DESAGNEAUX, MD

[email protected]

0463663337

Hospices Civils de Lyon, Lyon, France

Status

Recruiting

Address

Hospices Civils de Lyon

Lyon, , 69002

Site Contact

Anne d'Hombres, MD

[email protected]

0463663337

Centre Léon BÉRARD, Lyon, France

Status

Recruiting

Address

Centre Léon BÉRARD

Lyon, , 69373

Site Contact

Coralie MONCHARMONT, MD

[email protected]

0463663337

Centre Hospitalier d'Annecy-Genevois, Metz-Tessy, France

Status

Recruiting

Address

Centre Hospitalier d'Annecy-Genevois

Metz-Tessy, , 74370

Site Contact

Alexandre TESSIER, MD

[email protected]

0463663337

Institut de Cancérologie de l'Ouest, Saint-Herblain, France

Status

Recruiting

Address

Institut de Cancérologie de l'Ouest

Saint-Herblain, ,

Site Contact

François THYLLAYS, MD

[email protected]

0463663337

Saint-Priest-en-Jarez, France

Status

Not yet recruiting

Address

Institut de cancérologie de la Loire Lucien Neuwirth

Saint-Priest-en-Jarez, , 42270

Site Contact

Nicolas MAGNÉ, Pr

[email protected]

0463663337

Strasbourg, France

Status

Recruiting

Address

Institut de cancérologie Strasbourg Europe (ICANS)

Strasbourg, , 67000

Site Contact

Clara LEFEVRE, MD

[email protected]

0463663337

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