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RecruitingLast updated: 12 February 2024

PRISM: This study is examining whether a window of 7 to 21 days between radiation therapy and surgery is feasible for the treatment of non-small cell lung cancer and melanoma brain metastasesPRobing the Immunological Impact of Stereotactic Radiosurgery for Brain Metastases

Clinical summary

Summary

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.

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

Not applicable

Trial Acronym

PRISM

More information

Trial Identifiers

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Trial sponsor

Varian Medical Systems Australasia,Peter MacCallum Cancer Centre

Scientific Title

PRobing the Immunological Impact of Stereotactic Radiosurgery for Brain Metastases

Eligibility

Inclusion

• 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

• 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

Inclusion

  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

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