NCT07053033

Brief Summary

standard paradigm for management of patients who present with concern for recurrence of brain metastases following initial stereotactic radiosurgery (SRS).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
155

participants targeted

Target at P75+ for phase_2

Timeline
32mo left

Started Jan 2026

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress12%
Jan 2026Dec 2028

First Submitted

Initial submission to the registry

June 30, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 8, 2025

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2028

Last Updated

March 9, 2026

Status Verified

March 1, 2026

Enrollment Period

12 months

First QC Date

June 30, 2025

Last Update Submit

March 5, 2026

Conditions

Brain Metastases

Outcome Measures

Primary Outcomes (1)

  • Safety and Adverse Events (AEs)

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

    Through study completion; an average of 1 year

Study Arms (3)

Eligible for surgery or LITT-Surveillance

EXPERIMENTAL

Patients will be randomized in a 1:1 manner to close surveillance versus SRS2.

Procedure: SurgeryProcedure: LITT

Eligible for surgery or LITT-SRS2

EXPERIMENTAL

Patients will be randomized in a 1:1 manner to close surveillance versus SRS2.

Procedure: SurgeryProcedure: LITT

Ineligible for surgery or LITT-SRS2

EXPERIMENTAL

Patients will be randomized in a 1:1 manner to close surveillance versus SRS2.

Procedure: SurgeryProcedure: LITT

Interventions

SurgeryPROCEDURE

Participants will initially undergo craniotomy and surgical resection of lesions or LITT

Eligible for surgery or LITT-SRS2Eligible for surgery or LITT-SurveillanceIneligible for surgery or LITT-SRS2
LITTPROCEDURE

Participants will undergo 4-core stereotactic biopsy and LITT by experienced neurosurgeons with specific expertise.

Eligible for surgery or LITT-SRS2Eligible for surgery or LITT-SurveillanceIneligible for surgery or LITT-SRS2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ability to understand and the willingness to sign a written informed consent document.
  • Willingness to comply with all study procedures and availability for the duration of the study.
  • Age ≥18 years. Because no dosing or adverse event data are currently available on the use of SRS2, children are excluded from this study.
  • Karnofsky performance status ≥ 60.
  • Radiographic concern for progression of a solid tumor brain metastasis that has received prior stereotactic radiosurgery ≥ 3 months prior to study enrollment.
  • Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension as ≥5 mm with MRI scan.
  • Have active tumor on pathology from surgery/LITT for this lesion.
  • Able to safely undergo MRI imaging.
  • Acceptable candidate for SRS2 per treating physician and multidisciplinary conference consensus.
  • Have no radiographic evidence of leptomeningeal disease on radiology report or neuro-radiologist review.
  • Patients with a prior or concurrent malignancy whose natural history or treatment does not interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.

You may not qualify if:

  • Patients with brain metastases from hematologic malignancies due to significant differences in radiosensitivity and treatment paradigms.
  • Patients with psychiatric illness/social situations that would limit compliance with study requirements.
  • Postmenopausal (no menses in greater than or equal to 12 consecutive months).
  • History of hysterectomy or bilateral salpingo-oophorectomy.
  • Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).
  • History of bilateral tubal ligation or another surgical sterilization procedure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Subha Perni, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Subha Perni, MD

CONTACT

713-563-2543sperni@mdanderson.org

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2025

First Posted

July 8, 2025

Study Start

January 1, 2026

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2028

Last Updated

March 9, 2026

Record last verified: 2026-03

Locations

US(1)