Pre-operative Stereotactic Radiosurgery Followed by Resection for Brain Metastases

NCT02514915 | Completed Results DMC FDA Device

• 1 other identifier: HCC 14-150
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The primary goal of this research study is to determine the efficacy of giving pre-operative radiosurgery to patients pending resection of a brain metastasis.

Conditions

Malignant Neoplasm Brain

Outcome Measures

Primary Outcomes (3)

• Local Control Rate (LCR) at 6 Months

  The probability that patients experience a change in size of a tumor (measured by the amount of space taken up by the tumor). Tumor volume was measured at 6 months compared to the tumor volume at the start of radiotherapy.

  At 6 months

• Local Control Rate (LCR) at 12 Months

  The probability that patients experience a change in size of a tumor (measured by the amount of space taken up by the tumor). Tumor volume was measured at 12 months compared to the tumor volume at the start of radiotherapy.

  At 12 months

• Local Control Rate (LCR) at 24 Months

  The probability that patients experience a change in size of a tumor (measured by the amount of space taken up by the tumor). Tumor volume was measured at 24 months compared to the tumor volume at the start of radiotherapy.

  At 24 months

Secondary Outcomes (12)

• 6-month Overall Survival (OS)

  At 6 months

• 12-month Overall Survival (OS)

  At 12 months

• 24-month Overall Survival (OS)

  At 24 months

• Distant Intracranial Failure

  At 6 months

• Distant Intracranial Failure

  At 12 months

Study Arms (1)

Stereotactic Radiosurgery

OTHER

Subjects will receive stereotactic radiosurgery prior to resection

Radiation: Stereotactic Radiosurgery

Interventions

Stereotactic Radiosurgery RADIATION

Radiation therapy

Stereotactic Radiosurgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Life expectancy of at least 12 weeks
• Karnofsky performance status of at least 50
• No contraindications to MRI scanning with intravenous contrast.
• MRI scan consistent with brain metastasis as per radiology report.
• Target lesion must measure at least 15 mm in at least one dimension, and no more than 4 cm in any dimension.
• Patients must have an extra-cranial primary tumor diagnosis.
• Patients will have no more than 4 distinct lesions within the brain. At least 1 lesion has been recommended for surgical removal based on size, symptomology, or regional mass effect on the brain.
• Additional lesions will each be treated with stereotactic radiosurgery.
• Patients with a documented symptomatic lesion size smaller than 3cm requiring clinical surgical resection
• Must be aware of the neoplastic nature of his/her disease and willingly provide written, informed consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks and discomforts

You may not qualify if:

• Primary tumor histology of lymphoma, leukemia, multiple myeloma or germ cell tumor. Moribund status or status epilepticus.
• Supratentorial mass effect with greater than 5 mm of midline shift or hydrocephalus. Infratentorial mass effect with fourth ventricle effacement or hydrocephalus.
• More than four additional diagnosed brain metastases.
• Contraindication to general anesthesia.
• Adjacent tumor location to optic apparatus or brainstem, precluding achievement of meaningful dose with SRS.
• Primary brain tumor.
• Contraindication to MRI scans or intravenous contrast.
• Pregnant and breast-feeding females.

Sponsors & Collaborators

• Christopher Wilke: lead

Study Sites (1)

UPMC Shadyside Radiation Oncology Department

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Barbara Stadterman, MPH, CCRP, Clinical Research Manager
• Organization: UPMC Hillman Cancer Center

stadtermanbm@upmc.edu

4126233272

Study Officials

• Christopher A Wilke, MD, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: July 30, 2015
• First Posted: August 4, 2015
• Study Start: December 1, 2016
• Primary Completion: July 22, 2021
• Study Completion: July 22, 2021
• Last Updated: June 26, 2025
• Results First Posted: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)