RecruitingNot ApplicableNCT05124236
Trial of Preoperative Radiosurgery Versus Postoperative Stereotactic Radiotherapy for Resectable Brain Metastases
A Multicenter Prospective, Interventional, Randomized Trial of Preoperative Radiosurgery Compared With Postoperative Stereotactic Radiotherapy for Resectable Brain Metastases
Sponsor
Susanne Rogers
Enrollment
200 participants
Start Date
Jul 29, 2022
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria10
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Age ≥18
- Karnofsky performance status ≥60
- Histological diagnosis of a malignant primary or metastatic tumour
- Ability to take steroids
- No contraindication to magnetic resonance imaging (MRI)
- MRI-diagnosis of a clearly demarcated contrast-enhancing brain metastasis up to 4.0 cm diameter indicated for neurosurgical resection (tumorboard decision). Up to 3 other brain metastases suitable for primary radiosurgery/ stereotactic radiotherapy
- Survival estimated by primary clinician \> 12 months
- Platelet count \> 100/ml, INR \< 1.3, Hb \> 7.5 g/dL
Exclusion Criteria16
- Radiosensitive histology: germ cell tumour, lymphoma, multiple myeloma
- \>10 mm midline shift, effacement of the 4th ventricle or other sign of raised intracranial pressure requiring urgent decompressive surgery
- More than 4 brain metastases or the diameter of the metastasis for resection \>4.0 cm.
- More than 1 metastasis requiring resection
- Leptomeningeal disease in the CSF or on MRI (unless localized and can be irradiated then resected with the metastasis)
- Prior radiation to the brain (SRS/SRT to lesion to be resected and /or WBRT)
- Prior resection of a primary or secondary brain tumor
- Prior diagnosis of a non-meningioma brain tumor
- Prior radionuclide therapy within 30 days
- Prior anti-VEGF therapy within 6 weeks
- Unable to tolerate radiosurgery immobilization and treatment
- Inability to give informed consent
- Pregnancy or lactation
- Females of reproductive potential not willing to use effective contraception for at least 6 months after radiotherapy
- Males of reproductive potential not effective contraception for 3 months after radiotherapy
- Lack of likely compliance with protocol and follow-up
Interventions
RADIATIONpreoperative radiosurgery
single fraction radiosurgery
RADIATIONpostoperative hypofractionated stereotactic radiotherapy
fractionated stereotactic radiotherapy /radiosurgery in 1 to 6 fractions according to local standard of care
Locations(10)
View Full Details on ClinicalTrials.gov
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NCT05124236
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