Fractionated Stereotactic Radiosurgery for Large Brain Metastases

NCT02054689 | Completed Results DMC FDA Device

• 1 other identifier: HCC 11-091
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is a research trial that seeks to break up the total radiation dose into multiple smaller radiation treatments, termed fractionated stereotactic radiosurgery (FSRS) which may make the treatment feasible. Fractionated sterotatcic radiation, the risks of FSRS, and possible costs will be described later in this document. This clinical trial is for people who have had no prior whole brain radiation.

Conditions

Large Brain Mets

Outcome Measures

Primary Outcomes (2)

• Number of Patients Experiencing DLT

  The number of patients experiencing DLT, defined as the maximum amount of Gy fractionated stereotactic radiosurgery (FSRS) delivered without significant toxicity.

  Up to 3 years

• Maximum Tolerated Dose (MTD)

  The MTD was determined following a Time-to-Event Continual Reassessment Model which models toxicity as a function of dose. Treatment was given in 3 fractions (8-12 Gy/fx).

  Up to 24 months post completion of treatment

Secondary Outcomes (4)

• Best Response

  Up to 24 months after completion of treatment

• Local Control of Disease

  Up to 24 months after completion of treatment

• Regional Intracranial Failure

  Up to 24 months after completion of treatment

• Functional Assessment of Cancer Therapy - Brain (FACT-Br)

  Prior to treatment; 30 days post treatment; 8 -12 weeks, 22-28 weeks, 30-42 weeks, 45-60 weeks, 64-74 weeks, 80-84 weeks, 90-96 weeks,100-112 weeks, 120-124 weeks, 130-140 weeks, 145-155 weeks, and 160-170 weeks post treatment

Study Arms (1)

Fractionated Stereotactic Radiosurgery

OTHER

24 to 36 Gy in 3 fractions (8-12 Gy/fx).

Radiation: Fractionated Stereotactic Radiosurgery

Interventions

Fractionated Stereotactic Radiosurgery RADIATION

SRS SBRT CyberKnife Trilogy True Beam Radiosurgery

Also known as: SRS, SBRT, CyberKnife, Trilogy, True Beam, Radiosurgery

Fractionated Stereotactic Radiosurgery

Eligibility Criteria

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

You may qualify if:

• Male or female patients ≥ 18 years of age
• A life expectancy of at least 12 weeks with a Karnofsky performance status of at least 70 (Appendix II)
• The target lesion(s) can be accurately measured in at least one dimension according to RECIST
• No prior radiotherapy to the brain
• Previous or concurrent systemic or targeted chemotherapy is allowed
• Patients must have an extra-cranial primary tumor diagnosis
• Patients will have no more than 3 distinct lesions within the brain. At least 1 lesion must be a minimum of 3cm in greatest dimension, no larger than 5cm which will be treatable by fractionated stereotactic radiosurgery
• The additional lesions will each be treated with single fraction stereotactic radiosurgery
• Patient may be on steroids or anti-epileptics
• 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
• Patients do not need a histologically proven diagnosis of brain mets

You may not qualify if:

• Symptomatic patients in need of surgery to the "target" lesion
• Four or more newly-diagnosed lesions
• Prior surgical resection of targeted tumor
• Prior WBRT
• Primary brain tumor
• Pregnant or breast-feeding patients
• Primary tumor histology of lymphoma, leukemia, multiple myeloma or germ cell tumor

Sponsors & Collaborators

• Steven Burton: lead

Study Sites (1)

UPMC Shadyside Radiation Oncology

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Interventions

Radiosurgery

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

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

stadtermanbm@upmc.edu

4126475554

Study Officials

• Steve Burton, MD

  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 Associate Professor

Study Record Dates

• First Submitted: January 30, 2014
• First Posted: February 4, 2014
• Study Start: July 16, 2013
• Primary Completion: November 20, 2017
• Study Completion: March 9, 2023
• Last Updated: May 28, 2025
• Results First Posted: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)