Trial of Differential Margins in Single Isocenter Radiosurgery of Brain Metastases

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorUniversity of Alabama at Birmingham

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Stated willingness to comply with all study procedures and availability for the duration of the study

Male or female, aged 19 and older

Brain metastases diagnosis not requiring retreatment to the same tumor

For females of reproductive potential should undergo pregnancy testing as per UAB Radiation Oncology standard policies

Disqualifiers

Current use of cytotoxic chemotherapy within 3 days of treatment. There are no restrictions on the use of immunotherapy during treatment. TKIs known to be radiation sensitizers such as BRAF should be held at least 24 hours prior to treatment.

Inability to have MRI imaging

Pregnancy

Treatment with another investigational drug 14 days of enrollment

Trial design

Design model

Single group

Treatments tested in this trial

  • brain metastases radiosurgery

    Procedure/Surgery

    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.

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: 0mm marginActive comparator 1 intervention
Group B: 2mm marginActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Difference between 0mm and 2mm

Fisher's Exact Test to determine if (per patient) uncomplicated control is improved or worsened with the addition of a 2mm PTV margin in the treatment of brain metastases with single isocenter radiosurgery.

Time frame
12 months

Secondary outcomes

1

Maximum margin size of the tumor

To compare 0mm margin and 2mm margin radiosurgery for local tumor control, RANO assessment by individual tumor calculated by multiplying the longest diameter on an axial slice and its longest perpendicular diameter on the same slice

Time frame
12 months
2

Percentage of toxicity

To compare 0mm margin and 2mm margin radiosurgery for toxicity. NTCP - assessed per tumor and per patient, assign to all tumors if attribution ambiguous (only grade 3 or greater CNS toxicity included)

Time frame
12 months
3

Change in normal brain dosimetry

To compare 0mm margin and 2mm margin radiosurgery for normal brain dosimetry. * Dosimetry of normal brain (2 mm vs 0 mm) * Dosimetry of hippocampi (2 mm vs 0 mm)

Time frame
12 months

Other outcomes

Sponsors and contacts

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