Local ablative therapy for patients with multiple brain metastases
Local Ablative Therapy for Patients With Multiple (4-10) Brain Metastases
This study is testing how local radiation therapy affects the quality of life and treatment results for adults with multiple brain tumors from solid cancers.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Leuven) |
| Trial ID | NCT04397978 on ClinicalTrials.gov |
What this trial studies
This observational trial aims to assess the quality of life and report on toxicity and outcome parameters following local ablative therapy, specifically stereotactic radiotherapy, for patients with 4 to 10 brain metastases. The study will include adults diagnosed with multiple brain metastases from any solid tumor, who have a life expectancy of more than three months. Participants will receive stereotactic radiotherapy in 1 to 5 fractions, and the trial will focus on collecting data regarding their quality of life and treatment outcomes. The study is non-randomized and prospective, allowing for real-world insights into the effectiveness of this treatment approach.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with 4 to 10 synchronous brain metastases from solid tumors and a life expectancy of more than three months.
Not a fit: Patients with brain metastases not suitable for stereotactic radiotherapy or those with certain co-morbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the quality of life for patients with multiple brain metastases by providing effective local treatment options.
How similar studies have performed: Other studies have shown promising results with stereotactic radiotherapy for brain metastases, indicating that this approach is supported by existing evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male or female, ≥ 18 years of age 2. Minimal 4 and up to a maximum of 10 synchronous BM diagnosed on a high resolution contrast-enhanced MRI scan (T1 gadolinium) not dated more than 4 weeks prior to inclusion. 3. Maximal lesion diameter of single gross tumor volume (GTV) of 3 cm 4. Maximal cumulative GTV (+CTV for cavity) of 30cm3 5. Karnofsky performance status ≥ 70 6. DS-GPA or expected overall survival (if no DS-GPA applicable) of ≥ 1.5 or \>3 months respectively. 7. Any solid primary tumour. Lymphoma, germ cell tumor, small cell lung carcinoma and multiple myeloma are excluded. 8. Ability to provide written informed consent and to participate in the procedure of the questionnaires. Exclusion Criteria: 1. BM not amenable to SRT 2. Previous SRT or surgery on the same lesion 3. Co-morbidities considered clinically precluding the safe use of an MRI examination or SRT 4. Any psychological, sociological or geographical issue potentially hampering compliance with the study 5. Pregnancy 6. Concurrent use of systemic therapy 7. More than 10 BM on planning-MRI 8. Maximum cumulative GTV (+CTV for cavity) of more than 30cm3 on planning-MRI 9. A brainstem metastasis with a PTV of more than 20 cm3 10. Leptomeningeal disease
Where this trial is running
Leuven
- UZLeuven — Leuven, Belgium (Recruiting)
Study contacts
- Principal investigator: Patrick Berkovic, MD — UZ Leuven
- Study coordinator: Patrick Berkovic, MD
- Email: Patrick.berkovic@uzleuven.be
- Phone: +32-16-34-76-00
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.