Preoperative stereotactic radiosurgery for brain metastases
Phase II Study to Assess Preoperative Hypofractionated Stereotactic Radiotherapy of Brain Metastases
This study is testing if a special type of targeted radiation therapy before surgery can help control brain tumors in patients with certain cancers like breast, digestive, or lung cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Jean Perrin Academic / other |
| Locations | 8 sites (Clermont-Ferrand, Puy-de-Dôme and 7 other locations) |
| Trial ID | NCT04503772 on ClinicalTrials.gov |
What this trial studies
This phase II study evaluates the effectiveness of preoperative stereotactic radiosurgery (SRS) in achieving local control of brain metastases over a six-month period. It is a multicenter, prospective, non-randomized trial involving patients with up to four distinct brain metastases, one of which requires surgical intervention. The study aims to assess the impact of SRS on patients diagnosed with specific types of cancer, including breast, digestive, or non-small cell lung cancer.
Who should consider this trial
Good fit: Ideal candidates include adults with up to four brain metastases from specific cancers who are eligible for both surgery and stereotactic radiotherapy.
Not a fit: Patients with certain types of cancers such as lymphoma, leukemia, or small-cell lung cancer will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve local control of brain metastases and potentially enhance overall survival rates for patients.
How similar studies have performed: Other studies have shown promise with similar approaches, indicating potential for success in this novel application.
Eligibility criteria
Show full 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
Where this trial is running
Clermont-Ferrand, Puy-de-Dôme and 7 other locations
- Centre Jean PERRIN — Clermont-Ferrand, Puy-de-Dôme, France (Recruiting)
- CHU Grenoble Alpes — Grenoble, France (Recruiting)
- Hospices Civils de Lyon — Lyon, France (Recruiting)
- Centre Léon BÉRARD — Lyon, France (Recruiting)
- Centre Hospitalier d'Annecy-Genevois — Metz-Tessy, France (Recruiting)
- Institut de Cancérologie de l'Ouest — Saint-Herblain, France (Recruiting)
- Institut de cancérologie de la Loire Lucien Neuwirth — Saint-Priest-en-Jarez, France (Not_yet_recruiting)
- Institut de cancérologie Strasbourg Europe (ICANS) — Strasbourg, France (Recruiting)
Study contacts
- Principal investigator: Lucie BRUN, MD — Centre Jean Perrin
- Study coordinator: Angeline GINZAC COUVÉ, PhD
- Email: angeline.ginzac@clermont.unicancer.fr
- Phone: 0463663337
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.