Combining fractionated stereotactic radiosurgery with surgery for brain metastases
Prospective Clinical Study on the Efficacy of the Association of Fractionated SRS and Subsequent Surgery in Patients With Brain Metastases
NA · Regina Elena Cancer Institute · NCT06992973
This study is testing whether giving radiation therapy before surgery can help people with brain tumors from cancers like lung, breast, and melanoma have better outcomes and fewer complications.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 98 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Regina Elena Cancer Institute (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Rome) |
| Trial ID | NCT06992973 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of administering a preoperative dose of fractionated stereotactic radiosurgery (FSRT) to patients with brain metastases from solid tumors, such as lung, breast, and melanoma. The treatment involves delivering radiation therapy to the tumor before surgical resection, aiming to enhance local disease control and reduce the risk of complications like radionecrosis. By targeting the tumor while it is still intact, the study seeks to maximize the biological impact of the treatment and improve patient outcomes. The approach is designed to minimize the volume of healthy brain tissue exposed to radiation, thereby potentially lowering the risk of adverse effects.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with single or small resectable brain metastases from solid tumors.
Not a fit: Patients with contraindications to radiotherapy or those requiring urgent surgical intervention for neurological symptoms may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve local control of brain metastases and reduce complications associated with surgery.
How similar studies have performed: Previous studies have shown promising results with similar approaches, indicating potential for success in this novel treatment strategy.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients with single metastatic brain lesions with a diameter of ≥ 3 cm symptomatic / asymptomatic or with symptomatic brain lesions ≥ 2 cm \< 3 cm that are surgically resectable, without or in the presence of max 3 small synchronous lesions amenable to radiosurgery treatment; * no urgent surgical indication for neurological symptoms or worsening intracranial hypertension; * age ≥ 18 years; * performance status according to the Eastern Cooperative Oncology Group (ECOG) scales ≤ 2; * Karnfosky Performance Status ≥ 60; * life expectancy greater than 3 months; * patients assessed as suitable for surgery (ASA score ≤ 3) and in the absence of contraindications to undergoing brain MRI examination without and with contrast medium; * ability to understand and willingness to sign a written informed consent document. Exclusion Criteria: * contraindications to radiotherapy treatment; * pregnancy; * inability to follow the procedures, to fill out the questionnaires;
Where this trial is running
Rome
- "Regina Elena" National Cancer Institute — Rome, Italy (RECRUITING)
Study contacts
- Principal investigator: Stefano Telera, Doctor — IRCCS National Cancer Institute
- Study coordinator: Stefano Telera, Doctor
- Email: stefano.telera@ifo.it
- Phone: 0652662737
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.
Conditions: Brain Metastases