Brain MetastasesPhase 2NCT07227610
Brain Metastases in Greater Size - Hypofractionated Options Trial (BIGSHOT)
A Phase 2 study testing Staged Stereotactic Radiosurgery (SSRS) and Fractionated Stereotactic Radiotherapy (FSRT) in people with Brain Metastases and Cancer (With CNS Involvement), run by Medical University of South Carolina at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Metastases, Cancer (With CNS Involvement)
- What is being tested?
- Staged Stereotactic Radiosurgery (SSRS) and Fractionated Stereotactic Radiotherapy (FSRT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2026to 11 Jan 2032
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Radiographic confirmation of brain metastasis measuring ≥2 cm and ≤ 5 cm in maximum diameter
- Multiple metastases are allowed. Additional metastases will be treated with single fraction SRS as per standard of care. Up to 10 additional smaller metastases are allowed on protocol. All additional smaller metastases must be less than 2 cm.
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- If a patient has more than one large metastasis (measuring between 2 and 5 cm as above), up to two can be treated on study protocol
- All tumors must be ≥ 5mm from the optic chiasm and optic nerves.
- Known active or history of invasive non-CNS primary cancer based on documented pathologic diagnosis within the past 3 years
- Patient is able to medically tolerate SRS
- Patient is neurologically stable (immediate surgery not necessary or not recommended)
- A negative urine or serum pregnancy test (in persons of childbearing potential) within 7 days prior to registration. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal.
- Women who are sexually active must agree to use medically acceptable forms of contraception during treatment on this study to prevent pregnancy.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Medical University of South Carolina Hollings Cancer Center
Charleston, South Carolina, 29425
HCC Clinical Trials Office, 843-792-9321, hcc-clinical-trials@musc.edu
About this study
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.
Read the detailed description
Brain metastases are an increasingly common diagnosis, as cancer patients continue to live longer due to advances in systemic therapy. Up to 26% of patients with metastatic cancer will develop metastatic disease to the brain (Nayak 2012), most commonly in lung cancer, as well as melanoma, breast, and renal cell cancer (Singh 2020). Historically, brain metastases were treated with whole brain radiation therapy (WBRT). However, increasing evidence over the past 10-15 years, as well as technological advances, have created a shift in treatment toward stereotactic radiosurgery (SRS), which is a focused treatment targeting only the visible tumors. SRS has multiple advantages over WBRT. Most importantly, focused treatment with SRS provides significantly lower risk of neurocognitive toxicity compared with WBRT, with no difference in overall survival (Chang 2009, Brown 2016, Aoyama 2006). SRS is also more convenient, delivered in 1 to 3 treatments, as opposed to 2 weeks of therapy with WBRT. For these reasons, SRS is now the preferred option for patients with limited brain metastases, recognized in both the NCCN guidelines and ASTRO guidelines (Gondi 2022).
For intact metastases less than 2 cm, local control with SRS alone is excellent (Redmond 2021). However, for larger tumors, achieving long term local control with radiation is more difficult. Tumor dosing is based on risk of toxicity (specifically, radiation necrosis), and therefore for larger tumors, the dose is decreased (RTOG 90-05, Johannwerner 2023). This results in suboptimal control for tumors >2 cm. For single fraction SRS, local control is estimated around 70%, and for fractionated SRS (3-5 fractions), around 80% (Redmond 2021).
There are two common approaches for treating large intact brain metastases with radiosurgery alone. Fractionated SRS involves treating the tumor in 3-5 separate daily treatments. This allows for normal tissue recovery in between, and therefore may decrease the risk of toxicity (Minitti 2015). Staged SRS involves treating the tumor in two sessions, spaced apart by 3-6 weeks. This allows delivery of a lower dose for the first fraction (to minimize toxicity), and the second fraction can be dose escalated depending on interval tumor response. A recent meta-analysis compared SSRS to FSRT, and found no difference in local control, but a lower rate of re-treatment in the SSRS group (Harikar 2023). Radiation necrosis rate was 3.7% in the SSRS group and 6.4% in the FSRT group. The authors of this study concluded that randomized controlled trials examining the two options would be useful. A retrospective study conducted a propensity score-matched analysis of SSRS vs FSRT. This study showed comparable rates of local failure (15% at 6 months, and 25% at one year in both groups), as well as comparable rates of radiation necrosis (2.2% in SSRS vs 6.4% in FSRT) (Noda 2023).
In theory, treatment with SSRS would allow for a higher biological equivalent dose (BED) to the target lesion, while maintaining low toxicity rate, as time between fractions allows for normal tissue recovery. Retrospective data suggests that a BED10 > 50 predicts for better one year local control in hypofractionated SRS (Remick 2020). BED10 for 9 Gy x3 is 51.3Gy, with an EQD2 a/b 2 of 74.25. In comparison, 15 Gy x2 results in a BED10 of 75Gy, with EQD2 a/b 2 of 127.5. Allowing 3-6 weeks of recovery time in between the two fractions should theoretically allow for tissue recovery and mitigate the risk of higher normal tissue EQD2. Additionally, while data for 3 fraction FSRT is encouraging for larger tumors (2-5 cm), the local control for tumors on the larger end of this spectrum (>3 cm) may not be as good. Specifically, in one of the largest retrospective studies of 3 fraction FSRT for metastases >2cm, the overall local control was 91% at 1 year; however, the local control for lesions 3 cm or larger was only 73% (Minniti 2015).
Although there is encouraging retrospective data supporting the use of both SSRS and FSRT, there are no studies directly comparing the two approaches in a prospective fashion. Therefore, randomized data is needed to provide guidance on the best approach in this challenging patient population.
This study will compare two approaches for treating large brain metastases (2-5 cm): staged stereotactic radiosurgery (SSRS) and fractionated stereotactic radiotherapy (FSRT). These are both considered standard treatments and both used as standard of care for patients with large brain metastases.
- Conditions
- Brain Metastases, Cancer (With CNS Involvement)
- Being tested
- Staged Stereotactic Radiosurgery (SSRS), Fractionated Stereotactic Radiotherapy (FSRT)
- Keywords
- Cancer, Brain
- Medical subject headings
- Brain Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Staged Stereotactic Radiosurgery (SSRS) | Experimental | Patient will be scheduled for treatment with SSRS within one week of randomization. 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). MRI brain for planning purposes will be obtained either on the day of each treatment, or within 7 days prior to each treatment. Individual dosing for each fraction will be determined by the treating radiation oncologist, but total dose must equal 24-30 Gy. Any additional smaller metastases will be treated in a single fraction concurrently. Fixation for treatment will be either in a surgical headframe or mask. Receives: Radiation: Staged Stereotactic Radiosurgery (SSRS) |
| Fractionated Stereotactic Radiotherapy (FSRT) | Experimental | Patient will be scheduled for treatment with FSRT within one week of randomization. FSRT will be performed with mask fixation. Fractionation will be 27 Gy in 3 daily fractions or 25-30 Gy in 5 daily fractions. MRI for planning purposes must be completed within 7 days prior to delivery of first fraction. Any additional smaller metastases will be treated in 1-5 fractions concurrently (dose at the discretion of treating physician). Receives: Radiation: Fractionated Stereotactic Radiotherapy (FSRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 36 months.
Secondary outcomes (1)
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.
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2025
- Study start6 Feb 2026
- Primary completion11 Jan 2031 (estimated)
- Study completion11 Jan 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain MetastasesStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charlotte Rivers, Medical University of South Carolina
- Investigators
- Charlotte Rivers, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07227610
- Sponsor's protocol ID
- 104122
- Status last verified
- Sep 2026
- First submitted
- 10 Nov 2025
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified individual participant data (IPD) may be shared with qualified researchers upon request after the primary endpoint is completed. Requests should be directed to the Medical University of South Carolina.
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Metastases in Greater Size - Hypofractionated Options Trial (BIGSHOT)
- ClinicalTrials.gov ID
- NCT07227610
- Acronym / sponsor ID
- 104122
- Conditions
- Brain Metastases, Cancer (With CNS Involvement)
- Keywords
- Cancer, Brain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 6 Feb 2026 (actual)
- Primary completion
- 11 Jan 2031 (estimated)
- Study completion
- 11 Jan 2032 (estimated)
- First posted
- 12 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Brain metastases are an increasingly common diagnosis, as cancer patients continue to live longer due to advances in systemic therapy. Up to 26% of patients with metastatic cancer will develop metastatic disease to the brain (Nayak 2012), most commonly in lung cancer, as well as melanoma, breast, and renal cell cancer (Singh 2020). Historically, brain metastases were treated with whole brain radiation therapy (WBRT). However, increasing evidence over the past 10-15 years, as well as technological advances, have created a shift in treatment toward stereotactic radiosurgery (SRS), which is a focused treatment targeting only the visible tumors. SRS has multiple advantages over WBRT. Most importantly, focused treatment with SRS provides significantly lower risk of neurocognitive toxicity compared with WBRT, with no difference in overall survival (Chang 2009, Brown 2016, Aoyama 2006). SRS is also more convenient, delivered in 1 to 3 treatments, as opposed to 2 weeks of therapy with WBRT. For these reasons, SRS is now the preferred option for patients with limited brain metastases, recognized in both the NCCN guidelines and ASTRO guidelines (Gondi 2022).
For intact metastases less than 2 cm, local control with SRS alone is excellent (Redmond 2021). However, for larger tumors, achieving long term local control with radiation is more difficult. Tumor dosing is based on risk of toxicity (specifically, radiation necrosis), and therefore for larger tumors, the dose is decreased (RTOG 90-05, Johannwerner 2023). This results in suboptimal control for tumors >2 cm. For single fraction SRS, local control is estimated around 70%, and for fractionated SRS (3-5 fractions), around 80% (Redmond 2021).
There are two common approaches for treating large intact brain metastases with radiosurgery alone. Fractionated SRS involves treating the tumor in 3-5 separate daily treatments. This allows for normal tissue recovery in between, and therefore may decrease the risk of toxicity (Minitti 2015). Staged SRS involves treating the tumor in two sessions, spaced apart by 3-6 weeks. This allows delivery of a lower dose for the first fraction (to minimize toxicity), and the second fraction can be dose escalated depending on interval tumor response. A recent meta-analysis compared SSRS to FSRT, and found no difference in local control, but a lower rate of re-treatment in the SSRS group (Harikar 2023). Radiation necrosis rate was 3.7% in the SSRS group and 6.4% in the FSRT group. The authors of this study concluded that randomized controlled trials examining the two options would be useful. A retrospective study conducted a propensity score-matched analysis of SSRS vs FSRT. This study showed comparable rates of local failure (15% at 6 months, and 25% at one year in both groups), as well as comparable rates of radiation necrosis (2.2% in SSRS vs 6.4% in FSRT) (Noda 2023).
In theory, treatment with SSRS would allow for a higher biological equivalent dose (BED) to the target lesion, while maintaining low toxicity rate, as time between fractions allows for normal tissue recovery. Retrospective data suggests that a BED10 > 50 predicts for better one year local control in hypofractionated SRS (Remick 2020). BED10 for 9 Gy x3 is 51.3Gy, with an EQD2 a/b 2 of 74.25. In comparison, 15 Gy x2 results in a BED10 of 75Gy, with EQD2 a/b 2 of 127.5. Allowing 3-6 weeks of recovery time in between the two fractions should theoretically allow for tissue recovery and mitigate the risk of higher normal tissue EQD2. Additionally, while data for 3 fraction FSRT is encouraging for larger tumors (2-5 cm), the local control for tumors on the larger end of this spectrum (>3 cm) may not be as good. Specifically, in one of the largest retrospective studies of 3 fraction FSRT for metastases >2cm, the overall local control was 91% at 1 year; however, the local control for lesions 3 cm or larger was only 73% (Minniti 2015).
Although there is encouraging retrospective data supporting the use of both SSRS and FSRT, there are no studies directly comparing the two approaches in a prospective fashion. Therefore, randomized data is needed to provide guidance on the best approach in this challenging patient population.
This study will compare two approaches for treating large brain metastases (2-5 cm): staged stereotactic radiosurgery (SSRS) and fractionated stereotactic radiotherapy (FSRT). These are both considered standard treatments and both used as standard of care for patients with large brain metastases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Staged Stereotactic Radiosurgery (SSRS) | Experimental | Radiation: Staged Stereotactic Radiosurgery (SSRS)Patient will be scheduled for treatment with SSRS within one week of randomization. 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). MRI brain for planning purposes will be obtained either on the day of each treatment, or within 7 days prior to each treatment. Individual dosing for each fraction will be determined by the treating radiation oncologist, but total dose must equal 24-30 Gy. Any additional smaller metastases will be treated in a single fraction concurrently. Fixation for treatment will be either in a surgical headframe or mask. |
| Fractionated Stereotactic Radiotherapy (FSRT) | Experimental | Radiation: Fractionated Stereotactic Radiotherapy (FSRT)Patient will be scheduled for treatment with FSRT within one week of randomization. FSRT will be performed with mask fixation. Fractionation will be 27 Gy in 3 daily fractions or 25-30 Gy in 5 daily fractions. MRI for planning purposes must be completed within 7 days prior to delivery of first fraction. Any additional smaller metastases will be treated in 1-5 fractions concurrently (dose at the discretion of treating physician). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
- Radiographic confirmation of brain metastasis measuring ≥2 cm and ≤ 5 cm in maximum diameter
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Staged Stereotactic Radiosurgery (SSRS)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. | Radiation | Staged Stereotactic Radiosurgery (SSRS) |
| Fractionated Stereotactic Radiotherapy (FSRT)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. | Radiation | Fractionated Stereotactic Radiotherapy (FSRT) |
Primary outcome
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.
Time frame: Up to 36 months.
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.
1 secondary outcome
Compare the safety profile by radiation toxicity
Time frame: Up to 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) may be shared with qualified researchers upon request after the primary endpoint is completed. Requests should be directed to the Medical University of South Carolina.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Charlotte Rivers, MD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Staged Stereotactic Radiosurgery (SSRS) and Fractionated Stereotactic Radiotherapy (FSRT) in people with Brain Metastases and Cancer (With CNS Involvement), run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact HCC Clinical Trials Office (843-792-9321, hcc-clinical-trials@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Up to 36 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.