None listed
Conditions
Brief summary
This study aims to compare the safety and effectiveness of delivering focused radiotherapy (stereotactic radiosurgery or SRS) in either one session or three sessions before surgery in people with brain metastases. The goal is to find out whether spreading the radiation dose over multiple sessions before surgery improves cancer control and reduces side effects. Who is it for? You may be eligible for this study if you are aged 18 or over, have a confirmed diagnosis of a solid cancer that has spread to the brain, and your medical team has recommended SRS and surgery to remove at least one brain metastasis. Study details Participants in this study will receive focused radiotherapy (SRS) before undergoing surgery to remove brain metastases. All participants are randomly allocated to one of two treatment groups: a single session of SRS, or three smaller sessions of SRS on consecutive days before surgery. Tests may include imaging scans and other routine assessments to monitor treatment effects and side effects. This research hopes to improve how we treat brain metastases and reduce long-term complications, ultimately leading to better quality of life for people with advanced cancer.
Interventions
Preoperative Multi-fraction Pre-Stereotactic radiosurgery (SRS) of the index metastases planned for surgery on consecutive days
- Multi fraction (24Gy in 3 fractions (for lesions >3cm) or 27Gy in 3 fractions for lesions </= 3cm) to the index lesion(s) to be ideally be delivered within 7 days prior to surgery, but up to 14 days is permitted. The last fraction may be delivered on the same day as surgery.
- The radiation Oncologist will prescribe the radiation, define the targets on dedicated plann
Preoperative Multi-fraction Pre-Stereotactic radiosurgery (SRS) of the index metastases planned for surgery on consecutive days - Multi fraction (24Gy in 3 fractions (for lesions >3cm) or 27Gy in 3 fractions for lesions </= 3cm) to the index lesion(s) to be ideally be delivered within 7 days prior to surgery, but up to 14 days is permitted. The last fraction may be delivered on the same day as surgery. - The radiation Oncologist will prescribe the radiation, define the targets on dedicated planning imaging and review the dosimetry before approving the appropriate radiation plan that fits with the trial planning guidelines and credentialling requirements. Radiation will be delivered by the radiation therapist. - All Multi fraction radiation treatment should be ideally completed on consecutive days (i.e. over 3 days), however if the second or third fractions fall on a weekend or public holiday the final fraction (s) should be delivered on the first working day that the centre is operational again. - All participants to be treated with equipment capable of delivering stereotactic cranial radiotherapy (such as CyberKnife, GammaKnife or Linac)
Sponsors
Trans Tasman Radiation Oncology Group
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Age >/= 18 years • Histological or cytological confirmation of solid primary malignancy • Clinical indication for surgical resection of at least one brain metastasis (index lesion) as per the recommendation by the treating team (Maximum of 2 index lesions | Diameter of each index metastases (for surgery) < /= 4cm) • ECOG performance status < /=2 • Controlled or available treatment options for extra cranial disease
Exclusion criteria
• Considered unsuitable for cranial radiotherapy per local investigator discretion • Significant neurological symptoms or mass effect on radiology mandating urgent surgery (including but not limited to > 10mm midline shift, acute obstruction to CSF flow, major tumour related haemorrhage) • Index lesion < 5mm from the optic apparatus or located in the brainstem (unless dosimetry allows subthreshold dose to these structures) • Anti VEGF therapy within 4 weeks prior to screening • Prior cranial surgery within 12 months for malignant primary or secondary brain cancer • Previous radiotherapy to the index lesion/s or WBRT • WBRT planned immediately after surgery • MRI evidence of definite diffuse LMD at baseline and/or positive cerebrospinal fluid histology (if performed) • Not suitable for MRI brain with Gadolinium and follow up • Active or prior documented inherited hypersensitivity syndromes. For example, scleroderma, and systemic lupus erythematosus
Outcome results
None listed