C79.3
Conditions
Interventions
Group 1: The study intervention is a change in the timing and fractionation of radiotherapy from our current standard of 5 fractions of hypofractionated postoperative stereotactic radiotherapy with 5
Sponsors
Kantonsspital Aarau
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Age =18 4. Karnofsky performance status of at least 70 Histological diagnosis of a malignant primary or metastatic tumour 6. Ability to take steroids and no contraindication to MRI 7. MRI-diagnosed brain metastasis up to 4 cm diameter indicated for neurosurgical resection (tumor board decision). Up to 3 other brain metastases (up to 15cm3 in volume) for primary radiosurgery/stereotactic radiotherapy 8. Survival estimated by primary clinician >6 months (using the ds-GPA, Appendix 2) 9. Platelet count > 100/ml, INR 7.5 g/dL
Exclusion criteria
Exclusion criteria: 1. Radiosensitive histology: germ cell tumour, small cell lung cancer, lymphoma, multiple myeloma 2. > 10 mm midline shift, effacement of the 4th ventricle or other sign of raised intracranial pressure requiring urgent decompressive surgery 3. More than 4 brain metastases or total volume of non-resected BM>15cm3 4. Leptomeningeal disease in CSF or on MRI 5. Prior radiation to the brain (SRS/SRT to lesion to be resected and /or WBRT) 6. Prior radionuclide therapy within 30 days 7. Unable to tolerate radiosurgery immobilisation, duration of treatment 8. Inability to give informed consent 9. Pregnancy or lactation 10. Females of reproductive potential not willing to use effective contraception for at least 6 months after radiotherapy 11. Males of reproductive potential not effective contraception for 3 months after radiotherapy 12. Lack of likely compliance with protocol and follow-up
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the feasibility of administering preoperative radiosurgery and subsequent neurosurgery as assessed by delivery of therapy within the proposed timeframe of 6 working days | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints are incidence of leptomeningeal disease in patients treated with preoperative radiosurgery. Retrospective data suggest a reduction from around 16%-22% with postoperative hfSRT to 4% with preop SRS. The incidence of LMD will be evaluated on MRI imaging at 3, 6, 9 and at 12 months by a neuro-radiologist. The incidence of LMD can be affected by the number of BMs, hence limitation to 4. Breast cancer histology, infratentorial location, tumour size and piecemeal resection are additional risk factors for LMD Other secondary endpoint variables are rates of local control of the tumour bed, overall survival, neurological death, radionecrosis, quality of life and histological changes to determine whether preoperative irradiation alters the architecture as compared with the initial diagnostic material. | — |
Countries
Switzerland
Contacts
Public ContactSusanne Rogers
Radio-Onkologie-Zentrum KSA-KSB Kantonsspital Aarau
Outcome results
None listed