About this trial
Brain metastases (BM) are a common systemic cancer manifestation which incidence increases. Therapeutic options include whole-brain radiotherapy (WBRT), surgery, and stereotactic radiosurgery (SRS). The concept of "oligometastatic" cerebral disease (oligoBM) has emerged and led to consider alternative approaches. The main challenge is to preserve neurological function and independence the longest as possible.
Stereotactic radiotherapy (SRT) has emerged as an alternative treatment modality for selected oligoBM patients. It allows to achieve the balance of tumour destruction and normal tissue preservation by precisely and accurately delivering a very high dose of radiation in one (SRS) or a few (HSRT) fractions to a limited, well-defined volume. However, no standard exists for decision-making between SRS and HSRT and this important question is being discussed in the recent literature.
HSRT appears particularly interesting, assuming the patient convenience of few fractions, the normal tissue sparing achieved through focal irradiation, and the improved normal tissue tolerance of high dose radiation through fractionation.
Common adverse effects of SRT are rare but can occasionally be serious, notably radionecrosis that may induce neurological deficits in patients. Although SRS is often less well-tolerated, it remains the mainstay of treatment.
To investigators knowledge, SRS and HSRT have not been prospectively compared.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged ≥ 18 years
WHO performance status 0 or 1;
Patient eligible for SRT after a multidisciplinary committee decision; Patient with BMs from radioresistant cancer (renal cell carcinoma, sarcoma, melanoma) is eligible
Patient having up to 5 BM of solid tumours with an histologically proven diagnoses; patients who have had a metastasectomy and having 1 to 4 BM lesions is eligible (ANOCEF recommendations); post-operative cavity must be treated by radiosurgery according to local procedures with respect of non-inclusion criteria* (cavity will not be analyzed for efficacy)
Disqualifiers
Patients with current or past history small cell lung cancer, germ-cell tumours, lymphoma, leukemia and multiple myeloma within the last 5 years;
Patients with metastases in the brain stem, or within 1 cm of the optic apparatus;
Patients with an associated neurodegenerative disease;
Any symptoms not attributable to BM or cancer disease requiring long term corticosteroid use (regardless of dose);
Trial design
Parallel
Treatments tested in this trial
Hypofractionated SRT (stereotactic radiotherapy)
Radiation3\*10Gy over 1 week
Historical single-dose SRS (stereotactic radiosurgery)
Radiation20 to 25Gy/1 fraction
Treatment groups
Trial outcomes
Primary outcomes
Efficacy: Local control assessed by RANO-BM criteria
Secondary outcomes
Brain acute and late toxicities assessed by NCI CTCAE v5.0
Radionecrosis by RANO-BM criteria
Sponsors and contacts
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Centre Francois Baclesse
Lead sponsor
Association de Neuro-Oncologues d'Expression Francaise
Collaborator