An interventional study of preoperative radiosurgery and postoperative hypofractionated stereotactic radiotherapy in Brain Metastases, Adult, sponsored by Susanne Rogers. Recruiting at 10 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-04.
Sponsored by Susanne Rogers · Not applicable, Interventional, and Treatment
The research question is whether a single fraction of preoperative radiosurgery can reduce the incidence of leptomeningeal disease 12 months following resection of a brain metastasis (BM) as compared with 5 fractions of postoperative stereotactic radiotherapy.
Neurosurgical resection of a brain metastasis in patients with a diagnosis of cancer may be indicated however the recurrence rate approximates 50% and adjuvant radiotherapy is standard. Single fraction postoperative stereotactic radiosurgery (SRS) has been widely adopted as a standard therapy as it achieves equivalent survival and prevents loss of neurocognitive function as compared with whole brain radiotherapy and improves cavity local control rates as compared with observation. Hypofractionated stereotactic radiotherapy in 3 to 5 fractions (hfSRT) is also used in the postoperative setting.
Nodular leptomeningeal disease (nLMD) is a recognised pattern of failure after postoperative SRS and hfSRT. A 16.9% incidence of nodular LMD was seen after surgery and a similar incidence of 11%-28%is reported following postoperative SRS in retrospective series. These data suggest that postoperative SRS/hfSRT have no significant effect on the development of LMD following surgery.
The incidence of LMD following single fraction preoperative SRS is only 6.1% according to the largest retrospective series. Preoperative SRS takes advantage of the easier delineation of an intact BM and sterilizes tumor cells disseminated at surgery. Side effects are minimized by a smaller planning margin, a dose reduction and resection of the irradiated volume. In addition, there is no delay to systemic therapy due to wound healing/complications. Furthermore, a single fraction offers patient convenience.
This trial will randomise and compare intracranial outcomes between single fraction preoperative SRS and 5 fraction postoperative hFSRT.
1,960 studies on the registry are indexed under Brain Neoplasms; 516 are open to participants now.
This study's planned enrollment of 200 is above the median of 40 across 1,458 interventional studies indexed under Brain Neoplasms.
Browse Brain Neoplasms studies →This is the only study on the registry with Susanne Rogers as lead sponsor.
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Exclusion Criteria:
The interventional arm is single fraction preoperative radiosurgery to a brain metastasis identified for neurosurgical resection.
Radiation: preoperative radiosurgery
The active comparator arm is the standard of care of postoperative hypofractionated stereotactic radiotherapy to the surgical cavity in 5 fractions following resection of the brain metastasis.
Radiation: postoperative hypofractionated stereotactic radiotherapy
single fraction radiosurgery
fractionated stereotactic radiotherapy /radiosurgery in 1 to 6 fractions according to local standard of care
Leptomeningeal disease
time to leptomeningeal disease
Time frame: 12 months after intervention
Local control of the surgical cavity
No evidence of tumour recurrence on contrast-enhanced MRI
Time frame: 12 months after intervention
Distant brain failure
New brain metastases
Time frame: 12 months after intervention
Radionecrosis
Adverse radiation effects
Time frame: 12 months after intervention
Quality of life assessment
EORTC questionnaire core questionnaire QLQ30, EORTC questionnaire brain module BN 20 (1-4, low scores reflect better QoL)
Time frame: 3,6,12 months after intervention
Plan to share: No
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