At a glance
ClinicalIndex Comparison RecordN/ARecruiting· 200 target
Drug / intervention
preoperative radiosurgery +1 moreradiation
Likely dose
Not stated in record
Key inclusion· 13
- ✓Age 18 years or older
- ✓Karnofsky performance status at least 60
- ✓Histological diagnosis of malignant primary or metastatic tumor
- ✓Ability to tolerate steroids
Key exclusion· 11
- ✕Radiosensitive histology: germ cell tumor, lymphoma, multiple myeloma
- ✕Greater than 10 mm midline shift or effacement of 4th ventricle
- ✕More than 4 brain metastases or target metastasis diameter greater than 4.0 cm
- ✕More than 1 metastasis requiring resection
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter Prospective, Interventional, Randomized Trial of Preoperative Radiosurgery Compared With Postoperative Stereotactic Radiotherapy for Resectable Brain Metastases
In Brief
A clinical study evaluating preoperative radiosurgery and postoperative hypofractionated stereotactic radiotherapy for Brain Metastases, Adult. Currently recruiting, targeting 200 participants across 10 sites in 3 countries.
Signals
Enrolling ahead of pace
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBrain Metastases, Adult
CountriesAustria, Germany, Switzerland
CollaboratorsUniversity of Basel
Timeline
N/ARecruiting
20222023202420252026202720282029
First PostedNov 2021
Enrollment StartJul 2022
TodayJul 2026
Primary CompletionDec 2028
First PostedNov 17, 2021
Enrollment StartJul 29, 2022
Primary CompletionDec 30, 2028
TodayJul 2, 2026
Enrollment to primary: 6.4 yearsPosted 4.6 years agoPrimary completion in 2.5 years
Interventions
preoperative radiosurgeryradiation
single fraction radiosurgery
postoperative hypofractionated stereotactic radiotherapyradiation
fractionated stereotactic radiotherapy /radiosurgery in 1 to 6 fractions according to local standard of care