Trial of Differential Margins in Single Isocenter Radiosurgery of Brain Metastases

Last updated: April 15, 2025
Sponsor: University of Alabama at Birmingham
Overall Status: Active - Recruiting

Phase

N/A

Condition

Brain Metastases

Neoplasm Metastasis

Treatment

brain metastases radiosurgery

Clinical Study ID

NCT06857006
IRB-300014291 (UAB2507)
Robert Award
  • Ages > 19
  • All Genders

Study Summary

Radiosurgery is the use of a focal high dose of radiation therapy to ablate or kill a tumor. This trial will enroll patients with brain metastases 4 cm or less in greatest diameter and will compare 0mm margin to a 2mm margin for treatment.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Stated willingness to comply with all study procedures and availability for theduration of the study

  2. Male or female, aged 19 and older

  3. Brain metastases diagnosis not requiring retreatment to the same tumor

  4. For females of reproductive potential should undergo pregnancy testing as per UABRadiation Oncology standard policies

  5. Ability of subject or Legally Authorized Representative (LAR)) to understand and thewillingness to sign a written informed consent document.

Exclusion

Exclusion Criteria:

  1. Current use of cytotoxic chemotherapy within 3 days of treatment. There are norestrictions on the use of immunotherapy during treatment. TKIs known to beradiation sensitizers such as BRAF should be held at least 24 hours prior totreatment.

  2. Inability to have MRI imaging

  3. Pregnancy

  4. Treatment with another investigational drug 14 days of enrollment

  5. Radiosurgery planned for post-operative adjuvant cavity only. Patients with anygross residual after surgery are eligible. Patients with at least one intactmetastasis may enroll but adjuvant cavity will not be evaluable.

  6. At the time of Radiation Oncology consultation more than twenty targets areidentified. Note that it is common that a few additional metastases may beidentified during the treatment planning or peer review processes. More than twentytargets may be included if this number is found after the initial clinical review ofthe treatment planning MRI.

  7. Tumor maximal diameter > 4 cm.

  8. Prior SBRT or SRS to a lesion planned for retreatment. Note that patients with priorwhole brain radiation alone are eligible.

  9. Patients with diffuse leptomeningeal tumor are not eligible. Patients with a focaldural or pachymeningeal tumor are eligible if other intra-axial tumors are plannedto be treated. Similar to postoperative cavities, the pachymeningeal tumor depositwill be treated but not evaluable for the assessment of local control or toxicity.

INCLUSION OF VULNERABLE PARTICIPANTS Vulnerable populations as defined by the NIH including children, prisoners, and adult subjects who lack capacity to consent to research participation are not eligible.

Study Design

Total Participants: 180
Treatment Group(s): 1
Primary Treatment: brain metastases radiosurgery
Phase:
Study Start date:
April 08, 2025
Estimated Completion Date:
August 31, 2028

Study Description

Without a stereotactic frame there is considerable variation in practice in the use of planning target volume (PTV) margins for linac radiosurgery. In particular, the use of a single isocenter for multiple targets geometrically increases the risk that rotational errors will result in significant dosimetric errors, and many centers have considered adding margin. A recent AAPM task group survey has found that ~90% of centers worldwide add a PTV margin to account for error and that 8% add more than 2 mm. The most common margin is 2 mm. Other potential reasons to add a margin include spacial MRI error, couch walkout, CBCT to linac isocenter mismatch, and undetected intrafraction motion. Treatment volume is the greatest predictor of radiation toxicity associated with radiosurgery and potentially unnecessary margins will lead to increased risk to the patient. This trial will incorporate a composite endpoint that includes control of the tumor and toxicity.

Uncomplicated tumor control probability (UTCP) is defined as the chance the tumor is locally controlled (TCP) without grade 3 or greater CNS toxicity (1-NTCP). The investigators hypothesize a 2 mm margin will worsen uncomplicated control compared to a 0 mm PTV margin in the treatment multiple metastases in a single fraction.

This trial will inform the standard of care margin (0 mm vs 2 mm) for single isocenter treatment of multiple targets.

Connect with a study center

  • University of Alabama at Birmingham (UAB) Hazelrig-Salter Radiation Oncology Center

    Birmingham, Alabama 35249
    United States

    Active - Recruiting

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