Brain MetastasesRAD1705NCT03412812
A Dose Escalation Trial of Five Fraction Stereotactic Radiation Therapy for Brain Metastases
A study testing 6 Gy, 7 Gy and 8 Gy in people with Brain Metastases, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
This study looks at dose escalation for five fraction stereotactic radiotherapy for patients diagnosed with brain metastases with tumors 2.1-4.0 cm in diameter or 4.1-6.0 cm in diameter. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Metastases
- What is being tested?
- 6 Gy, 7 Gy and 8 Gy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2018to 1 Oct 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- All patients must have histologically confirmed malignancy.
- All patients must have imaging suggestive of one or more brain metastases.
- Karnofsky performance status (KPS) ≥ 60
- Age > 18 years
- Patients must provide written informed consent to participate in the study.
- Patients must have less than or equal to 10 brain metastases as identified on brain MRI.
Who cannot join
- History of surgical resection to the tumor of interest
- History of radiation to the tumor of interest
- History of previous whole brain irradiation
- Receipt of systemic therapy within one week of planned radiation treatment except for hormonal agents.
- Patient is unable to have MRI or MRI contrast.
- Inability to meet the appropriate normal tissue dose constraints secondary to tumor location should result in exclusion of the patient / tumor.
- Patients with a non-index tumor (second tumor) greater than 3 cm in diameter will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hazelrig-Salter Radiation Oncology Center
Birmingham, Alabama, 35233
About this study
Official title: A Phase I Dose Escalation Trial of Five Fraction Stereotactic Radiation Therapy for Brain
This study looks at dose escalation for five fraction stereotactic radiotherapy for patients diagnosed with brain metastases with tumors 2.1-4.0 cm in diameter or 4.1-6.0 cm in diameter.
Read the detailed description
This study looks at dose escalation treatment in patients diagnosed with brain metastases. Treatment involve five fraction stereotactic radiotherapy for patients with brain tumors 2.1-4.0 cm in diameter or 4.1-6.0 cm in diameter and dose escalation treatment is delivered only to the single largest tumor while all other tumors are treated with standard of care practices if they are present. A dose escalation schedule is proposed based on the monitoring of CNS toxicity and tumor size of the largest tumor, given it falls into the parameters set on diameter.
- Conditions
- Brain Metastases
- Being tested
- 6 Gy, 7 Gy, 8 Gy, 9 Gy
- Keywords
- Brain Metastases, Stereotactic Radiosurgery
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6 GyRadiation
As focal radiation techniques are utilized more frequently in the treatment of brain metastases, there is increasing need to accurately define the appropriate patient and tumor characteristics for focal therapy. Unfortunately, not all patients are good candidates for single fraction stereotactic radiosurgery (SRS) since large tumors and those in unfavorable locations have been associated with unacceptable rates of treatment-related toxicity. Five fraction stereotactic radiation has proven to be a more effective treatment for these patients that aren't good candidates.
7 GyRadiation
As focal radiation techniques are utilized more frequently in the treatment of brain metastases, there is increasing need to accurately define the appropriate patient and tumor characteristics for focal therapy. Unfortunately, not all patients are good candidates for single fraction stereotactic radiosurgery (SRS) since large tumors and those in unfavorable locations have been associated with unacceptable rates of treatment-related toxicity. Five fraction stereotactic radiation has proven to be a more effective treatment for these patients that aren't good candidates.
8 GyRadiation
As focal radiation techniques are utilized more frequently in the treatment of brain metastases, there is increasing need to accurately define the appropriate patient and tumor characteristics for focal therapy. Unfortunately, not all patients are good candidates for single fraction stereotactic radiosurgery (SRS) since large tumors and those in unfavorable locations have been associated with unacceptable rates of treatment-related toxicity. Five fraction stereotactic radiation has proven to be a more effective treatment for these patients that aren't good candidates.
9 GyRadiation
As focal radiation techniques are utilized more frequently in the treatment of brain metastases, there is increasing need to accurately define the appropriate patient and tumor characteristics for focal therapy. Unfortunately, not all patients are good candidates for single fraction stereotactic radiosurgery (SRS) since large tumors and those in unfavorable locations have been associated with unacceptable rates of treatment-related toxicity. Five fraction stereotactic radiation has proven to be a more effective treatment for these patients that aren't good candidates.
| Study group | Role | What they receive |
|---|---|---|
| 2.1-4.0 cm diameter | Experimental | Patients will undergo dose escalated five fraction stereotactic radiosurgery for diagnosed brain metastases. Only single largest tumor will be treated with dose escalation. All other tumors (if present) will be treated with standard of care five fraction stereotactic radiosurgery. Starting dose level 7 Gy x 5 fractions Receives: Radiation: 7 Gy; Radiation: 8 Gy; Radiation: 9 Gy |
| 4.1-6.0 cm diameter | Experimental | Patients will undergo dose escalated five fraction stereotactic radiosurgery for diagnosed brain metastases. Only single largest tumor will be treated with dose escalation. All other tumors (if present) will be treated with standard of care five fraction stereotactic radiosurgery. Starting dose level 6 Gy x 5 fractions. Receives: Radiation: 6 Gy; Radiation: 7 Gy; Radiation: 8 Gy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose of Five Fraction Stereotactic Radiotherapy
To determine the maximum tolerated dose of five fraction stereotactic radiotherapy for patients with either tumors 2.1-4.0 cm in diameter or 4.1-6.0 cm in diameter
Measured: 1-2 years
Secondary outcomes (3)
Acute Toxicity of Five Fraction Stereotactic Radiotherapy Using Adverse Event Questionnaire
To assess the acute toxicity of five fraction stereotactic radiotherapy for tumors 2-6 cm in diameter using the RAD 1705 Adverse Events Assessment. This assessment was created within our department and will be used specifically for this study.
Measured: 1-2 years
Late Toxicity of Five Fraction Stereotactic Radiotherapy Using Adverse Event Questionnaire
To assess the late toxicity of five fraction stereotactic radiotherapy for tumors 2-6 cm in diameter using the RAD 1705 Adverse Events Assessment. This assessment was created within our department and will be used specifically for this study.
Measured: 1-2 years
Rate of Local Tumor Control With Five Fraction Stereotactic Radiotherapy Using Adverse Event Questionnaire
To determine the rate of local tumor control with five fraction stereotactic radiotherapy for tumors 2-6 cm in diameter using the RAD 1705 Adverse Events Assessment. This assessment was created within our department and will be used specifically for this study.
Measured: 1-2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2018
- Study start30 Jul 2018
- Primary completion19 Jan 2024
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Brain MetastasesStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Fiveash, MD, University of Alabama at Birmingham
- Investigators
- John B Fiveash, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03412812
- Sponsor's protocol ID
- IRB-300001065
- Acronym
- RAD1705
- Status last verified
- Oct 2025
- First submitted
- 29 Dec 2017
- Last updated
- 4 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Dose Escalation Trial of Five Fraction Stereotactic Radiation Therapy for Brain
- ClinicalTrials.gov ID
- NCT03412812
- Acronym / sponsor ID
- RAD1705 / IRB-300001065
- Conditions
- Brain Metastases
- Keywords
- Brain Metastases, Stereotactic Radiosurgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 30 Jul 2018 (actual)
- Primary completion
- 19 Jan 2024 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 26 Jan 2018 (actual)
- Results
- Posted 16 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study looks at dose escalation for five fraction stereotactic radiotherapy for patients diagnosed with brain metastases with tumors 2.1-4.0 cm in diameter or 4.1-6.0 cm in diameter.
Detailed description
This study looks at dose escalation treatment in patients diagnosed with brain metastases. Treatment involve five fraction stereotactic radiotherapy for patients with brain tumors 2.1-4.0 cm in diameter or 4.1-6.0 cm in diameter and dose escalation treatment is delivered only to the single largest tumor while all other tumors are treated with standard of care practices if they are present. A dose escalation schedule is proposed based on the monitoring of CNS toxicity and tumor size of the largest tumor, given it falls into the parameters set on diameter.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2.1-4.0 cm diameter | Experimental | Radiation: 7 Gy, Radiation: 8 Gy, Radiation: 9 GyPatients will undergo dose escalated five fraction stereotactic radiosurgery for diagnosed brain metastases. Only single largest tumor will be treated with dose escalation. All other tumors (if present) will be treated with standard of care five fraction stereotactic radiosurgery. Starting dose level 7 Gy x 5 fractions |
| 4.1-6.0 cm diameter | Experimental | Radiation: 6 Gy, Radiation: 7 Gy, Radiation: 8 GyPatients will undergo dose escalated five fraction stereotactic radiosurgery for diagnosed brain metastases. Only single largest tumor will be treated with dose escalation. All other tumors (if present) will be treated with standard of care five fraction stereotactic radiosurgery. Starting dose level 6 Gy x 5 fractions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- All patients must have histologically confirmed malignancy.
- All patients must have imaging suggestive of one or more brain metastases.
- Karnofsky performance status (KPS) ≥ 60
- Age > 18 years
- Patients must provide written informed consent to participate in the study.
Key exclusion criteria (7 listed)
- History of surgical resection to the tumor of interest
- History of radiation to the tumor of interest
- History of previous whole brain irradiation
- Receipt of systemic therapy within one week of planned radiation treatment except for hormonal agents.
- Patient is unable to have MRI or MRI contrast.
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 |
|---|---|---|
| 6 GyAs focal radiation techniques are utilized more frequently in the treatment of brain metastases, there is increasing need to accurately define the appropriate patient and tumor characteristics for focal therapy. Unfortunately, not all patients are good candidates for single fraction stereotactic radiosurgery (SRS) since large tumors and those in unfavorable locations have been associated with unacceptable rates of treatment-related toxicity. Five fraction stereotactic radiation has proven to be a more effective treatment for these patients that aren't good candidates. | Radiation | 4.1-6.0 cm diameter |
| 7 GyAs focal radiation techniques are utilized more frequently in the treatment of brain metastases, there is increasing need to accurately define the appropriate patient and tumor characteristics for focal therapy. Unfortunately, not all patients are good candidates for single fraction stereotactic radiosurgery (SRS) since large tumors and those in unfavorable locations have been associated with unacceptable rates of treatment-related toxicity. Five fraction stereotactic radiation has proven to be a more effective treatment for these patients that aren't good candidates. | Radiation | 2.1-4.0 cm diameter, 4.1-6.0 cm diameter |
| 8 GyAs focal radiation techniques are utilized more frequently in the treatment of brain metastases, there is increasing need to accurately define the appropriate patient and tumor characteristics for focal therapy. Unfortunately, not all patients are good candidates for single fraction stereotactic radiosurgery (SRS) since large tumors and those in unfavorable locations have been associated with unacceptable rates of treatment-related toxicity. Five fraction stereotactic radiation has proven to be a more effective treatment for these patients that aren't good candidates. | Radiation | 2.1-4.0 cm diameter, 4.1-6.0 cm diameter |
| 9 GyAs focal radiation techniques are utilized more frequently in the treatment of brain metastases, there is increasing need to accurately define the appropriate patient and tumor characteristics for focal therapy. Unfortunately, not all patients are good candidates for single fraction stereotactic radiosurgery (SRS) since large tumors and those in unfavorable locations have been associated with unacceptable rates of treatment-related toxicity. Five fraction stereotactic radiation has proven to be a more effective treatment for these patients that aren't good candidates. | Radiation | 2.1-4.0 cm diameter |
Primary outcome
Maximum Tolerated Dose of Five Fraction Stereotactic Radiotherapy
Time frame: 1-2 years
To determine the maximum tolerated dose of five fraction stereotactic radiotherapy for patients with either tumors 2.1-4.0 cm in diameter or 4.1-6.0 cm in diameter
3 secondary outcomes
Acute Toxicity of Five Fraction Stereotactic Radiotherapy Using Adverse Event Questionnaire
Time frame: 1-2 years
Late Toxicity of Five Fraction Stereotactic Radiotherapy Using Adverse Event Questionnaire
Time frame: 1-2 years
Rate of Local Tumor Control With Five Fraction Stereotactic Radiotherapy Using Adverse Event Questionnaire
Time frame: 1-2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Brain Metastases
RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
Epidural Hydroxyethyl Starch for Post-Dural Puncture Headache in Parturients
Parturients, Accidental Puncture of Dura During Anaesthesia
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
RecruitingPhase 2/3
RO7771950 Versus Tucatinib in Combination With Trastuzumab and Capecitabine in People With Locally Advanced or Metastatic Breast Cancer That is Human Epidermal Growth Factor Receptor 2 (HER2)-Positive
HER2-positive Breast Cancer
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. This study is not recruiting at the moment.
John B Fiveash, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 6 Gy, 7 Gy and 8 Gy in people with Brain Metastases, run by University of Alabama at Birmingham 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 6 inclusion and 7 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: finished, as of the sponsor's last update on 4 Nov 2025. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose of Five Fraction Stereotactic Radiotherapy (time frame: 1-2 years). 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 4 Nov 2025.