Stereotactic Radiation for Growing/Changing Brain Metastases With Same-Day Radiation Planning and Treatment With Margin Reduction

NCT07132190 | Recruiting Phase 2 DMC FDA Device

• 1 other identifier: 25-133
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to evaluate the feasibility and effectiveness of same-day radiation planning and treatment. The study will shorten the time interval between radiation planning (radiation mapping) and radiation treatment. The intent of this shorter time interval is to increase the likelihood that the brain metastases being treated remain fully within the high-dose radiation fields. Participants will be randomized to receive brain-directed stereotactic radiation with a 1mm margin or 0mm margin, have their simulation/radiation planning imaging on the same day that brain-directed stereotactic radiation is delivered, and have repeat simulation/radiation planning scans during the course of treatment if more than 2-3 days have elapsed since the most recent scans.

Conditions

Brain Metastases, Adult; Brain Tumor - Metastatic; Brain Metastases From Non-small Cell Lung Cancer (NSCLC); Brain Metastases From Extra-cranial Solid Tumors

Keywords

Brain Mets; Brain Metastases; Brain-directed stereotactic radiation; Brain radiation; Volatile Brain Metastases; Intracranial lesion; SRS; SRT; RANO; PTV; Planning Target Volume; Local Recurrence; Radiation Necrosis; Adaptive; VMAT; Volumetric Modulated Arc Therapy; Margin; Volatile; Rapid; Growth; Shift; neurocognitive; quality of life; survival; same day; randomized

Outcome Measures

Primary Outcomes (1)

• To assess the percentage of patients that demonstrate tumor beyond the standard planning margin (1.0mm PTV) at the time of stereotactic treatment.

  Percentage of patients, based on clinical and radiographic assessment, in which the repeat same day/simulation MRI reveals tumor extending beyond a 1.0mm PTV margin of the plan developed on the diagnostic MRI (i.e. the percentage of patients for which the MRI obtained on the same or first day of treatment displays tumor extending 1.0mm beyond the extent of the tumor on the planning MRI).

  Diagnostic MRI to MRI on first day of treatment

Secondary Outcomes (16)

• Overall survival

  Duration of time on study (estimated 1 year)

• Death due to neurologic disease progression

  Duration of time on study (estimated 1 year)

• Performance status

  Duration of time on study (estimated 1 year)

• Progression free survival

  Duration of time on study (estimated 1 year)

• Quality of life/symptom burden and interference

  Duration of time on study (estimated 1 year)

Study Arms (2)

0mm PTV

EXPERIMENTAL

0mm uncertainty margin

Radiation: Linear accelerator-based stereotactic radiation for brain metastases using 0mm or 1mm PTV

1mm PTV

ACTIVE COMPARATOR

1mm uncertainty margin

Radiation: Linear accelerator-based stereotactic radiation for brain metastases using 0mm or 1mm PTV

Interventions

Linear accelerator-based stereotactic radiation for brain metastases using 0mm or 1mm PTV RADIATION

Linear accelerator-based stereotactic radiation for brain metastases using 0mm or 1mm PTV

Also known as: SRS, SRT

0mm PTV; 1mm PTV

Eligibility Criteria

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

You may qualify if:

• Participants must have a biopsy proven solid malignancy with at least one intact, residual or recurrent, intracranial lesion radiographically consistent with or pathologically proven to be a brain metastasis meeting one of the following criteria:
• Growth of 1.0mm per week or more, on average, based on the two most recent brain MRIs preceding study enrollment
• Abutment, to within 1.0cm, of a region of intracranial edema
• Proximity (within 5.0cm) to a surgical cavity created within 30 days of enrollment
• Proximity (within 5.0cm) to another source of physical displacement
• Age of at least 18 years
• Karnofsky performance status of at least 60
• Estimated survival of at least 3-6 months in the opinion of the enrolling clinician and/or study PI
• Ability to understand and the willingness to sign a written informed consent document by either ink on paper or a DF/HCC approved eConsent medium

You may not qualify if:

• Participants who cannot tolerate a brain MRI
• Patients who cannot receive gadolinium
• Participants with end stage renal disease
• Participants with widespread, definitive leptomeningeal disease
• Pregnant women are excluded from this study because of the potential deleterious effects of gadolinium on the developing fetus. Because there is an unknown but potential risk for adverse events in nursing infants, women who are breastfeeding are not eligible for this study as well

Sponsors & Collaborators

• Ayal A. Aizer, MD: lead
• Varian, a Siemens Healthineers Company: collaborator

Study Sites (1)

Brigham and Women's Hospital / Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms; Margins of Excision; Fasting

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms; Feeding Behavior; Behavior

Study Officials

• Ayal A Aizer, MD, MHS

  Dana-Farber/Brigham and Women's Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ayal A Aizer, MD, MHS

CONTACT

(617) 732-7560; aaaizer@partners.org

Ivy B Ricca, BA

CONTACT

(617) 582-8927; iricca@mgb.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Central Nervous System Radiation Oncology; Associate Professor, Harvard Medical School

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 20, 2025
• Study Start: December 30, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2029
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

US (1)