Skip to content

Feasibility study of delayed neurosurgical resection following pre-operative stereotactic radiosurgery for non-small cell lung cancer and melanoma brain metastases

PRISM: PRobing the Immunological Impact of Stereotactic Radiosurgery for Brain Metastases

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622001372774
Acronym
PRISM
Enrollment
15
Registered
2022-10-26
Start date
2023-01-01
Completion date
Unknown
Last updated
2022-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose of this study is to examine if a window of 7 to 21 days between radiotherapy and surgery is feasible for metastatic brain cancer. Who is it for? You may be eligible for this study if you are aged 18 years or older, have been diagnosed with non-small cell lung cancer (NSCLC) or melanoma, and have confirmed metastatic brain cancer. Study details All participants in this study will undergo radiation therapy to individual brain tumours. This will be performed as per standard clinical practice, and involves 1-5 outpatient visits to the Peter MacCallum Cancer Centre for treatment. In general, each treatment will take approximately 30 minutes. Blood tests will be performed before radiation therapy, and at 1 week, 4 weeks, and 3 months after radiation therapy. These blood tests will coincide with follow-up appointments with a doctor. After radiation therapy is completed, 7-21 days later there will be surgery to remove the radiation-treated brain tumours. The surgery will be performed as per standard clinical practice at the Royal Melbourne Hospital. There will be a few days of hospital stay after the surgery. Brain cancer tissue from surgery will be collected for this study. It is hoped that this research will reveal if having a window of 7 to 21 days between radiation therapy and surgery for brain cancers is beneficial, and lead to better outcomes for cancer patients.

Interventions

This is a single arm study examining the feasibility of neurosurgical resection 7-21 days following completion of pre-operative stereotactic radiosurgery (SRS) for brain metastases (BMs), where clinically appropriate. This is in contrast to the current practice where there is no standardised time frame between SRS and neurosurgery. Translational blood and tumour tissue will also be obtained. 1. Stereotactic radiosurgery (SRS) SRS is a highly precise form of radiation therapy (RT) that delivers

This is a single arm study examining the feasibility of neurosurgical resection 7-21 days following completion of pre-operative stereotactic radiosurgery (SRS) for brain metastases (BMs), where clinically appropriate. This is in contrast to the current practice where there is no standardised time frame between SRS and neurosurgery. Translational blood and tumour tissue will also be obtained. 1. Stereotactic radiosurgery (SRS) SRS is a highly precise form of radiation therapy (RT) that delivers high doses of radiation in a few treatment fractions (typically 20-25Gy in 1-5 fractions) to individual BM tumours while sparing the surrounding normal brain tissue. For the patient this will involve first a planning CT scan as an outpatient, followed by 1-5 daily outpatient treatment visits to the Peter MacCallum Cancer Centre. Each treatment session will take approximately 30 minutes, depending on the number and size of lesions treated. This treatment is non-invasive and there will be no incision or general anaesthesia involved. 2. Neurosurgical resection of brain metastasis (BM) Following completion of SRS treatment, neurosurgical resection of the BM will be scheduled to take place 7-21 days later. This will be performed at the Royal Melbourne Hospital and will involve a few days of hospital stay after the surgery (usually 2-4 days). The patient will be under general anaesthesia during the procedure, which lasts approximately 4-6 hours. During the hospital stay patient's are monitored regularly by the neurosurgeon and hospital staff. 3. Collection of translational tissue Pre- and post-SRS bloods will be collected at 4 time points over 6 months, to coincide with routine follow-up appointments. The resected BM tissue will also be banked for research purposes. No additional resections or biopsies on top of standard of care treatments are necessary for this study. All specimens collected will be de-identified. After treatment: Trial participants will be reviewed as part of the study at 1 week, 4 weeks, 3 months and 6 months after completion of SRS. MRI scans of the brain be organised at 3 months post SRS. This follow-up schedule is standard for all patients having SRS and neurosurgery.

Sponsors

Peter MacCallum Cancer Center
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

• Aged 18 years or older • Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) or melanoma • Brain metastases (BMs) confirmed on MRI – there is no limit on the number or size of BM(s) planned for SRS; only one irradiated BM needs to be resected, at least • ECOG performance status 0-2 • Suitable for treatment with combined SRS and neurosurgery • Suitable for collection of peripheral blood • Be able to provide written Informed Consent for participation in this study

Exclusion criteria

• Previous intracranial RT (WBRT or SRS) PRISM Protocol Version 1.0 Page 13 of 32 • Need for urgent BM resection for relief of mass effect or symptoms (as per clinician judgment) • Steroid requirement of dexamethasone > 4 mg/day or equivalent • Diffuse leptomeningeal disease • Planned (adjuvant) WBRT after SRS • Pregnant or breastfeeding

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 5, 2026