Study on Pre-Operative Stereotactic Radiosurgery and Surgery for Treating Brain Metastases

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05267587

This clinical trial is exploring whether using a specialized type of radiation therapy before surgery can improve outcomes for patients with brain metastases compared to the current standard treatment.

Patient Parameters

Program Overview

The aim of this study is to find out if giving a specific type of radiation treatment, called hypofractionated stereotactic radiosurgery (fSRS), before surgery can help delay the return of brain metastases. This approach will be compared to the usual care to see if it offers better results for patients.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of a solid tumor cancer, excluding lymphoma or germ cell tumors. A brain biopsy is not needed unless the doctor thinks the diagnosis is uncertain.
  • Expected to live for at least 3 months, as determined by a specialist in brain cancer treatment.
  • Have at least one brain metastasis between 10 mm and 60 mm in size that can be surgically removed, and has not been treated with Stereotactic Radiosurgery (SRS) before.
  • Any additional brain lesions must be 4.0 cm or smaller and not require surgery. The number of these lesions will be decided by the doctor, as long as whole brain radiotherapy is not used.
  • Have no symptoms from brain metastases or symptoms that are well managed with steroids.
  • Can continue systemic treatments like immunotherapy or chemotherapy if the doctor agrees.
  • Have a Karnofsky Performance Status (KPS) score of 60 or higher, indicating the ability to care for oneself with some assistance.
  • Can rejoin the study if they left before starting treatment, but must agree again to participate.
  • Women who can become pregnant must have a negative pregnancy test within 7 days before starting radiation.
  • Men who cannot father children and women who are not sexually active with men are exempt from using contraception but must still take a pregnancy test.
  • Doctors will discuss the importance of preventing pregnancy and recommend effective birth control methods to participants who are sexually active.

Exclusion Criteria

  • Have germ cell tumors, primary brain tumors, or lymphoma.
  • Have symptoms from brain metastases that cannot be controlled with steroids.
  • Are pregnant or breastfeeding.
  • Women who can become pregnant and are not using effective birth control.
  • Are not medically fit for brain surgery due to other health issues, as determined by the neurosurgeon.
  • Have had whole brain radiation in the last three months.
  • Have had previous radiation targeting the main brain lesion.
  • Have a main brain lesion located in the brainstem.
  • Have certain imaging findings, such as widespread leptomeningeal metastasis or significant brain swelling.
  • Have a brain metastasis within 2 mm of the optic chiasm.
  • Have certain genetic or autoimmune conditions that increase sensitivity to radiation.
  • Cannot undergo an MRI with contrast or are allergic to gadolinium.
  • Are receiving certain chemotherapy treatments 7 days before or during fSRS.
  • Cannot follow the treatment plan due to normal tissue tolerance limits.
  • Cannot or do not want to attend all follow-up visits.
  • Are prisoners or involuntarily incarcerated.
  • Are detained for treatment of psychiatric or physical illnesses.

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