Ignite Creation Date:
2024-05-06 @ 3:11 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04545814
Status:
COMPLETED
Last Update Posted:
2023-11-28
First Post:
2020-09-04
Brief Title:
Analyzing Preoperative Stereotactic Radiosurgery With Gamma Knife Icon for Brain Metastases
Sponsor:
Medical College of Wisconsin
Organization:
Medical College of Wisconsin
Study Overview
Official Title:
A Pilot Study Analyzing Preoperative Stereotactic Radiosurgery SRS With Gamma Knife GK for Brain Metastases
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a single-arm single-center pilot study in which 10 patients with one to four brain metastases diagnosed on brain magnetic resonance imaging MRI within the past 30 days will be evaluated for study eligibility and enrolled as appropriate
Detailed Description:
INTERVENTION Enrolled patients will receive stereotactic radiosurgery SRS to all metastases followed by surgical resection of resectable metastases within one to 10 days following SRS Pathologic specimens will be analyzed and the patient will enter a standard pattern of surveillance brain MRI every three months for two years
STUDY RATIONALE Given the increased risk of leptomeningeal failure with surgery followed by SRS as well as the risk of radiation necrosis new paradigms in therapy delivery and sequencing are being explored Areas of investigation include optimization of target volume marginal expansion multi-fractionation timeliness of SRS after surgery and delivery of SRS prior to surgical resection In theory advantages of preoperative SRS include better target delineation sterilization of tumor cells prior to surgical disruption of the tumor vascular supply and CSF spaces and resection of tissue that would otherwise be at risk of radiation necrosis
In 2014 Asher et al Asher AL Burri SH Wiggins WF et al A new treatment paradigm neoadjuvant radiosurgery before surgical resection of brain metastases with analysis of local tumor recurrence Int J Radiat Oncol Biol Phys 201488899-906 reported that the use of neoadjuvant SRS prior to surgery was both safe and effective even for metastases 3 cm with no reported leptomeningeal recurrences or radiation necrosis More recently Patel et al Patel KR Burri SH Asher AL et al Comparing Preoperative With Postoperative Stereotactic Radiosurgery for Resectable Brain Metastases A Multi-institutional Analysis Neurosurgery 201679279-85 performed a retrospective comparison of preoperative versus postoperative SRS and reported no difference in local control distant brain failure or overall survival Furthermore the authors reported significantly lower rates of leptomeningeal carcinomatosis and radiation necrosis with preoperative SRS
Huff et al Huff WX Agrawal N Shapiro S et al Efficacy of pre-operative stereotactic radiosurgery followed by surgical resection and correlative radiobiological analysis for patients with 1-4 brain metastases study protocol for a phase II trial Radiat Oncol 201813252 recently published a protocol for a phase II prospective trial designed to compare outcomes using preoperative SRS versus historically cited outcomes for postoperative SRS This pilot study mirrors this design and aims to confirm study feasibility and to assess local control central nervous system CNS progression-free survival overall survival rates of leptomeningeal spread rates of radiation necrosis and quality of life measures with the use of preoperative SRS
STUDY RATIONALE Given the increased risk of leptomeningeal failure with surgery followed by SRS as well as the risk of radiation necrosis new paradigms in therapy delivery and sequencing are being explored Areas of investigation include optimization of target volume marginal expansion multi-fractionation timeliness of SRS after surgery and delivery of SRS prior to surgical resection In theory advantages of preoperative SRS include better target delineation sterilization of tumor cells prior to surgical disruption of the tumor vascular supply and CSF spaces and resection of tissue that would otherwise be at risk of radiation necrosis
In 2014 Asher et al Asher AL Burri SH Wiggins WF et al A new treatment paradigm neoadjuvant radiosurgery before surgical resection of brain metastases with analysis of local tumor recurrence Int J Radiat Oncol Biol Phys 201488899-906 reported that the use of neoadjuvant SRS prior to surgery was both safe and effective even for metastases 3 cm with no reported leptomeningeal recurrences or radiation necrosis More recently Patel et al Patel KR Burri SH Asher AL et al Comparing Preoperative With Postoperative Stereotactic Radiosurgery for Resectable Brain Metastases A Multi-institutional Analysis Neurosurgery 201679279-85 performed a retrospective comparison of preoperative versus postoperative SRS and reported no difference in local control distant brain failure or overall survival Furthermore the authors reported significantly lower rates of leptomeningeal carcinomatosis and radiation necrosis with preoperative SRS
Huff et al Huff WX Agrawal N Shapiro S et al Efficacy of pre-operative stereotactic radiosurgery followed by surgical resection and correlative radiobiological analysis for patients with 1-4 brain metastases study protocol for a phase II trial Radiat Oncol 201813252 recently published a protocol for a phase II prospective trial designed to compare outcomes using preoperative SRS versus historically cited outcomes for postoperative SRS This pilot study mirrors this design and aims to confirm study feasibility and to assess local control central nervous system CNS progression-free survival overall survival rates of leptomeningeal spread rates of radiation necrosis and quality of life measures with the use of preoperative SRS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None