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Pre-operative Stereotactic Radiosurgery Followed by Resection for Patients With Brain Metastases

NCT03398694 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-07-16

No results posted yet for this study

Summary

This is a prospective, single arm, phase II trial to determine the local control at 6 months utilizing pre-operative stereotactic radiosurgery followed by surgery within 1 - 4 days in subjects with a diagnosis of 1-4 brain metastases and with an indication for surgical resection of at least one brain metastasis at the discretion of a neurosurgeon.

Conditions

Interventions

PROCEDURE

Radiosurgery

Stereotactic radiosurgery will be delivered on all patients utilizing gamma knife or linear accelerator based techniques as per RTOG-9005 dosing criteria (Section 11 Table 1) based on tumor diameter with the exception that the largest lesion diameter to be treated with 15 Gy will be 5 cm. All apparent, previously untreated brain metastases will be treated with radiosurgery at this time. Radiosurgery will be performed 1-4 days prior to surgical resection. Vital signs and MRI Brain planning scan will be performed on the day of radiosurgery prior to the procedure.

Sponsors & Collaborators

  • Indiana University

    lead OTHER

Principal Investigators

  • Namita Agrawal, MD · Indiana University School of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-26
Primary Completion
2022-08-26
Completion
2024-05-21

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03398694 on ClinicalTrials.gov