Phase III Trial of Single Fraction Stereotactic Radiosurgery (SRS) Versus Fractionated SRS (FSRS) for Intact Brain Metastases

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Low burden on patient More information

Trial Details

Sponsor: NRG Oncology (other)

Phase: 3

Start date: Dec. 12, 2024

Planned enrollment: 269

Trial ID: NCT06500455
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More trial details at ClinicalTrials.gov More info

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Investigational Drug AI Analysis

No investigational drugs.

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Goal: To determine whether fractionated stereotactic radiosurgery (FSRS) improves time to local failure compared to single-fraction stereotactic radiosurgery (SRS) in patients with unresected brain metastases from solid tumors.

Patients: Adults (age 18 or older) with one of several solid tumor malignancies (including NSCLC, melanoma, breast, renal cell, or GI cancers) who have 1-8 intact (unresected), non-brainstem brain metastases on MRI (1.0-3.0 cm), good performance status (KPS ≥60), and no previous brain radiotherapy, leptomeningeal disease, or significant uncontrolled comorbidities.

Design: Randomized phase III trial.

Treatments: The trial compares standard single-fraction SRS (1 session) versus FSRS (3 sessions over several days). Both are well-established, non-invasive, outpatient radiotherapy techniques delivered with high precision to minimize exposure to normal brain tissue.

Outcomes: The primary outcome is time to local failure of the treated brain metastasis. Secondary outcomes include intracranial progression-free survival, overall survival, patterns of CNS failure, rates of radiation necrosis, time to salvage whole brain radiotherapy, and incidence of adverse events. Time to local failure will also be analyzed by imaging central review and among different demographic groups.

Burden on patient: Patient burden is relatively low, as both arms involve standard radiotherapy approaches without additional experimental interventions or invasive procedures. The FSRS arm does require two more treatment visits compared to SRS. Follow-up CT and MRI imaging are necessary, but this is consistent with usual surveillance in this population. The required follow-up schedule is every 3 months for the first year, then less frequently up to 5 years, which is in line with standard practice for patients with brain metastases.

Last updated: Aug 2025

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Columbus, Ohio, 43210, United States

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Status: Recruiting

Saint Elizabeth Youngstown Hospital

Youngstown, Ohio, 44501, United States

No email / No phone

Status: Active, not recruiting

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

[email protected] / 405-271-8777

Status: Recruiting

Providence Portland Medical Center

Portland, Oregon, 97213, United States

[email protected] / 503-215-2614

Status: Recruiting

Providence Saint Vincent Medical Center

Portland, Oregon, 97225, United States

[email protected] / 503-215-2614

Status: Recruiting

Legacy Meridian Park Hospital

Tualatin, Oregon, 97062, United States

No email / 503-413-1742

Status: Recruiting

Clackamas Radiation Oncology Center

Clackamas, Oregon, 97015, United States

[email protected] / 503-215-2614

Status: Recruiting

Legacy Good Samaritan Hospital and Medical Center

Portland, Oregon, 97210, United States

[email protected] / 800-220-4937

Status: Recruiting

Legacy Mount Hood Medical Center

Gresham, Oregon, 97030, United States

No email / 503-413-2150

Status: Recruiting

Saint Luke's University Hospital-Bethlehem Campus

Bethlehem, Pennsylvania, 18015, United States

No email / 484-503-4151

Status: Recruiting

Chambersburg Hospital

Chambersburg, Pennsylvania, 17201, United States

[email protected] / 412-339-5294

Status: Recruiting

Northeast Radiation Oncology Center

Dunmore, Pennsylvania, 18512, United States

No email / 888-808-6762

Status: Recruiting

Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States

[email protected] / 717-531-3779

Status: Recruiting

NRG Oncology

Philadelphia, Pennsylvania, 19103, United States

[email protected] / 786-999-4267

Status: Recruiting

University of Pennsylvania/Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States

[email protected] / 855-216-0098

Status: Recruiting

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

[email protected] / 215-600-9151

Status: Recruiting

Jefferson Torresdale Hospital

Philadelphia, Pennsylvania, 19114, United States

[email protected] / 215-600-9151

Status: Recruiting

UPMC-Presbyterian Hospital

Pittsburgh, Pennsylvania, 15213, United States

No email / 412-647-2811

Status: Recruiting

UPMC-Shadyside Hospital

Pittsburgh, Pennsylvania, 15232, United States

No email / 412-621-2334

Status: Recruiting

Saint Luke's Hospital - Upper Bucks Campus

Quakertown, Pennsylvania, 18951, United States

No email / 610-776-4714

Status: Recruiting

Reading Hospital

West Reading, Pennsylvania, 19611, United States

No email / 610-988-9323

Status: Recruiting

WellSpan Health-York Cancer Center

York, Pennsylvania, 17403, United States

No email / 877-441-7957

Status: Recruiting

WellSpan Health-York Hospital

York, Pennsylvania, 17403, United States

No email / 877-441-7957

Status: Recruiting

Saint Luke's Cancer Center - Allentown

Allentown, Pennsylvania, 18104, United States

No email / 610-776-4714

Status: Recruiting

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, 57117-5134, United States

[email protected] / 605-312-3320

Status: Recruiting

Sanford Cancer Center Oncology Clinic

Sioux Falls, South Dakota, 57104, United States

[email protected] / 605-312-3320

Status: Recruiting

Vanderbilt Breast Center at One Hundred Oaks

Nashville, Tennessee, 37204, United States

No email / 800-811-8480

Status: Recruiting

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, 37232, United States

No email / 800-811-8480

Status: Recruiting

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

[email protected] / 210-450-3800

Status: Recruiting

MD Anderson in The Woodlands

Conroe, Texas, 77384, United States

[email protected] / 866-632-6789

Status: Recruiting

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Houston, Texas, 77030, United States

[email protected] / 713-798-1354

Status: Recruiting

M D Anderson Cancer Center

Houston, Texas, 77030, United States

[email protected] / 877-632-6789

Status: Recruiting

Memorial Hermann Texas Medical Center

Houston, Texas, 77030, United States

No email / 713-792-3245

Status: Recruiting

MD Anderson West Houston

Houston, Texas, 77079, United States

[email protected] / 877-632-6789

Status: Recruiting

MD Anderson League City

League City, Texas, 77573, United States

[email protected] / 877-632-6789

Status: Recruiting

MD Anderson in Sugar Land

Sugar Land, Texas, 77478, United States

[email protected] / 877-632-6789

Status: Recruiting

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, 84112, United States

[email protected] / 888-424-2100

Status: Recruiting

University of Vermont and State Agricultural College

Burlington, Vermont, 05405, United States

[email protected] / 802-656-8990

Status: Recruiting

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

[email protected] / 802-656-4101

Status: Recruiting

VCU Massey Comprehensive Cancer Center

Richmond, Virginia, 23298, United States

[email protected] / 804-628-6430

Status: Recruiting

Legacy Cancer Institute Medical Oncology and Day Treatment

Vancouver, Washington, 98684, United States

[email protected] / No phone

Status: Recruiting

Legacy Salmon Creek Hospital

Vancouver, Washington, 98686, United States

No email / 503-413-2150

Status: Recruiting

Valley Medical Center

Renton, Washington, 98055, United States

[email protected] / 425-228-3440

Status: Recruiting

ThedaCare Regional Cancer Center

Appleton, Wisconsin, 54911, United States

[email protected] / 920-364-3604

Status: Recruiting

University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

Madison, Wisconsin, 53718, United States

[email protected] / 800-622-8922

Status: Recruiting

University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin, 53792, United States

[email protected] / 800-622-8922

Status: Recruiting

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

No email / 414-805-3666

Status: Recruiting

Aspirus Cancer Care - James Beck Cancer Center

Rhinelander, Wisconsin, 54501, United States

[email protected] / 715-847-2353

Status: Recruiting

Aspirus Cancer Care - Stevens Point

Stevens Point, Wisconsin, 54481, United States

[email protected] / 715-847-2353

Status: Recruiting

Aspirus Regional Cancer Center

Wausau, Wisconsin, 54401, United States

No email / 877-405-6866

Status: Recruiting

Aspirus Cancer Care - Wisconsin Rapids

Wisconsin Rapids, Wisconsin, 54494, United States

No email / 715-422-7718

Status: Recruiting

Langlade Hospital and Cancer Center

Antigo, Wisconsin, 54409, United States

[email protected] / 715-623-9869

Status: Recruiting

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