Moffitt Cancer Center
Tampa, Florida, 33612, United States
NCT Number: NCT05267587
The purpose of the study is to determine whether treatment with pre-operative hypofractionated stereotactic radiosurgery followed by surgery will improve time to local failure (TTLF) compared to the current standard of care.
This study is active but is not currently recruiting participants.
18 year and older
All sexes
Interventional
Phase 2
Tampa, Florida, 33612, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Widespread definitive leptomeningeal metastasis Infratentorial mass effect with fourth ventricle effacement or hydrocephalus Supratentorial mass effect with greater than 10 mm of midline shift or hydrocephalus.
A brain metastasis that is located within 2 mm of the optic chiasm
Participants will be given hypofractionated stereotactic radiosurgery (fSRS) in 9 Gray Units (Gy) per fraction x 3 consecutive daily fractions (27 Gy total) to the index metastasis that will be resected.
Time frame: up to 12 months
Time from surgery until first occurrence of Intracranial Progression or death. If none of these events occur, patients will be censored on date of last contact.
Time frame: up to 12 months
Time from surgery to death, censoring at the last contact date if no deaths.
Time frame: at 6 months
Local control rate is defined as the freedom from local progression
Time frame: at 12 months
Local control rate is defined as the freedom from local progression
Time frame: at 12 months
Rate of LMD is defined as the percentage of participants that progressed to leptomeningeal disease
Time frame: at 12 months
Rate of distant brain recurrence defined as the percentage of participants that experienced distant brain recurrence
H. Lee Moffitt Cancer Center and Research Institute
Other
Pre-operative Hypofractionated Stereotactic Radiosurgery for Resectable Brain Metastases
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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