Brain Metastases in Greater Size - Hypofractionated Options Trial (BIGSHOT)

ConditionsBrain Metastases Cancer (With CNS Involvement)

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorMedical University of South Carolina

About this trial

This is a randomized, phase II trial comparing staged stereotactic radiosurgery (SSRS) versus fractionated stereotactic radiotherapy (FSRT) in patients with large brain metastases (≥2 cm and ≤5 cm). The study aims to evaluate efficacy, safety, and tumor response between these two standard-of-care radiation approaches.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The patient or a legally authorized representative must be able and willing to provide study-specific informed consent prior to study entry.

Patient must be willing to comply with all study procedures and available for the duration of the study

Male or female, aged ≥ 18 years

Karnofsky Performance Status (KPS) ≥ 60 within 7 days prior to registration

Disqualifiers

Prior cranial radiotherapy, including whole brain radiotherapy (WBRT), or SRS in the area of the large metastasis to be treated on study.

Evidence of leptomeningeal disease (LMD) Note: For the purposes of exclusion, LMD is a clinical diagnosis, defined as positive CSF cytology and/or unequivocal radiologic or clinical evidence of leptomeningeal involvement. Patients with leptomeningeal symptoms in the setting of leptomeningeal enhancement by imaging (MRI) would be considered to have LMD even in the absence of positive CSF cytology. In contrast, an asymptomatic or minimally symptomatic patient with mild or nonspecific leptomeningeal enhancement (MRI) would not be considered to have LMD. In such cases, CSF sampling is not required to formally exclude LMD, but can be performed at the investigator's discretion based on level of clinical suspicion.

Inability to undergo MRI with contrast

Planned administration of systemic therapy (chemotherapy or immunotherapy) within 3 days prior to, the day of, or 3 days after completion of SRS.

Trial design

Design model

Parallel

Treatments tested in this trial

Staged Stereotactic Radiosurgery (SSRS)
Radiation
The large brain metastasis (or metastases) will be treated to a dose of 24-30 Gy in two fractions. Interval between the two fractions will be 30 days (+/- 10 days). Individual dosing for each fraction will be determined by the treating radiation oncologist, but total dose must equal 24-30 Gy.
Fractionated Stereotactic Radiotherapy (FSRT)
Radiation
Fractionation will be 27 Gy in 3 daily fractions or 25-30 Gy in 5 fx. If using 3 daily fractions, they must be completed over a period of 3-5 days. If using 5 daily fractions, they must be completed over a period of 5-10 days. Treatment with 3 or 5 daily fractions is at the discretion of the treating physician.

Treatment groups

54 Participants

are divided into 2 treatment groups

Group A: Staged Stereotactic Radiosurgery (SSRS)Experimental treatment 1 intervention

Group B: Fractionated Stereotactic Radiotherapy (FSRT)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

Time to Composite unfavorable outcome (CUO) by (1) lack of local control (disease progression for any lesion treated on study); (2) the need for further intervention to the treated tumor; (3) radiation necrosis.

For lesions \> 5 mm: Disease progression is defined as at least a 50% increase in the product of the two longest diameters of the target lesion, compared to the smallest product measured for that lesion. For lesions ≤ 5mm on the baseline scan, disease progression is defined as at least a 100% increase in the product of the two longest diameters of the target lesion, compared to the smallest product measured for the same lesion. * Radiation necrosis is defined by: pathologic diagnosis after resection or biopsy; OR initiation of steroids, and follow up MRI scan shows decrease in edema and stability of contrast of enhancing lesion that was concerning for radiation necrosis. * Radiation necrosis is NOT counted as disease progression. * Additional interventions include surgical resection, LITT (laser interstitial thermal therapy), or re-irradiation to the target lesion.

Time frame

Up to 36 months.

Secondary outcomes

Compare the safety profile by radiation toxicity

Radiation toxicity defined as need for prolonged steroids (\>2 weeks) due to symptoms related to the treated tumor.

Time frame

Up to 36 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical University of South Carolina

Lead sponsor

Source ClinicalTrials.gov

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