None listed
Conditions
Brief summary
This study will investigate the feasibility of performing stereotactic radiosurgery prior to operative management to remove brain lesions in patients with metastatic breast or non-small cell lung cancer. Who is it for? You may be eligible for this study if you are aged 18 or older and have confirmed metastatic breast cancer or non-small cell lung cancer with between 1-4 identified brain lesions that require surgical removal. Study details Participants enrolled in this study will attend a radiotherapy planning appointment where they will undergo a brain CT scan and a MRI brain. At the time of the CT scan a stereotactic radiotherapy mask will be made for immobilisation during radiotherapy treatment. Radiation treatment will take place after an appropriate treatment plan has been formulated. Within 48 hours of the stereotactic radiotherapy a neurosurgeon will then operate to remove the cancer tissue from the brain. Participants will then be asked to attend follow-up visits with their doctor and have regular follow up MRI scans, as normal, and information regarding their disease progress after the procedure will be shared with the research team. Participants will also be asked to complete a short study questionnaire about their satisfaction with the radiosurgery intervention at 6 and 12 months after the procedures were completed. It is hoped this research will demonstrate that the combination of radiotherapy prior to surgical intervention for the treatment of brain lesions is feasible, and that a larger trial to investigate the efficacy of these treatments for cancer patients can be conducted in the future.
Interventions
This study will investigate the feasibility of performing stereotactic radiosurgery prior to operative management to remove brain lesions in patients with metastatic breast or non-small cell lung cancer.
Participants enrolled in this study will attend a radiotherapy planning appointment where they will undergo a brain CT scan and a MRI brain, these scans should occur within 2 weeks of the radiotherapy treatment and must be performed at the treating centre. At the time of the CT scan a stereotac
This study will investigate the feasibility of performing stereotactic radiosurgery prior to operative management to remove brain lesions in patients with metastatic breast or non-small cell lung cancer. Participants enrolled in this study will attend a radiotherapy planning appointment where they will undergo a brain CT scan and a MRI brain, these scans should occur within 2 weeks of the radiotherapy treatment and must be performed at the treating centre. At the time of the CT scan a stereotactic radiotherapy mask will be made for immobilisation during radiotherapy treatment. A single radiation treatment will take place after an appropriate treatment plan has been formulated. The dose will depend of the size of the lesion (<2.5cm diameter=16Gy, 2.5-3cm diameter=14Gy and 3.1-4cm diameter=12Gy). This treatment is likely to take less than 2 hours. Within 48 hours of the stereotactic radiotherapy a neurosurgeon will then operate to remove the cancer tissue from the brain. Surgical intervention is not anticipated to take any longer as a result of the neo-adjuvant radiotherapy. Participants will then be asked to attend follow-up visits with their doctor and have regular follow up MRI scans, as normal, and information regarding their disease progress after the procedure will be shared with the research team. Participants will also be asked to complete a short study questionnaire about their satisfaction with the radiosurgery intervention at 6 and 12 months after the procedures were completed.
Sponsors
St Vincent's Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Histologically confirmed metastatic breast cancer and non-small cell lung cancer • New intra-cranial metastases requiring surgical resection for reduction of symptoms or mass effect • MRI evidence of 1-4 brain metastases • >/= 18 years age • Not pregnant or breast feeding • No other cancer diagnosis for >5years excluding non-melanomatous skin cancer • Willingness to give written informed consent and willingness to participate in and comply with the study. • ECOG performance status 0-2 • Deemed appropriate for surgical management by Neurosurgeon • Combined size of all lesions < /=30cm3
Exclusion criteria
• Non-breast or NSCLC histopathology • Metastases >4cm max diameter • Number of metastases >5 • Previous whole brain radiotherapy • Patients unfit for surgery • Patients who have had bevacizumab systemic therapy within the last 6 weeks • Any contra-indications to anaesthetic • Any contra-indications to MRI
Outcome results
None listed