Brain Metastases
Conditions
Keywords
Brain Metastases, Stereotactic Radiosurgery
Brief 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.
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.
Interventions
RADIATION6 Gy
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.
RADIATION7 Gy
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.
RADIATION8 Gy
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.
RADIATION9 Gy
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.
Sponsors
University of Alabama at Birmingham
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Tolerated Dose of Five Fraction Stereotactic Radiotherapy | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute Toxicity of Five Fraction Stereotactic Radiotherapy Using Adverse Event Questionnaire | 1-2 years | 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. |
| Late Toxicity of Five Fraction Stereotactic Radiotherapy Using Adverse Event Questionnaire | 1-2 years | 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. |
| Rate of Local Tumor Control With Five Fraction Stereotactic Radiotherapy Using Adverse Event Questionnaire | 1-2 years | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Capturing Patient Reported Outcomes Electronically Using FACT-Br Questionnaire | 1-2 years | To assess the feasibility of capturing patient reported outcomes with the Functional Assessment of Cancer Therapy-Brain Questionnaire (FACT-Br) electronically in the Radiation Oncology clinic |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 2.1-4.0 cm diameter 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. | 12 |
| 4.1-6.0 cm diameter 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. | 1 |
| Total | 13 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Level 1 | Adverse Event | 0 | 1 |
| Level 1 | Death | 3 | 0 |
Baseline characteristics
| Characteristic | 2.1-4.0 cm diameter | 4.1-6.0 cm diameter | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 0 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 1 Participants | 9 Participants |
| Age, Continuous | 65 years | 65 years | 65 years |
| Race/Ethnicity, Customized Race Black or African American | 3 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized Race White | 9 Participants | 1 Participants | 10 Participants |
| Region of Enrollment United States | 12 participants | 1 participants | 13 participants |
| Sex: Female, Male Female | 7 Participants | 1 Participants | 8 Participants |
| Sex: Female, Male Male | 5 Participants | 0 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 1 |
| other Total, other adverse events | 0 / 12 | 0 / 1 |
| serious Total, serious adverse events | 6 / 12 | 1 / 1 |
Outcome results
Primary
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
Time frame: 1-2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dose Escalated 5 Fraction Stereotactic Radiosurgery - 2.1-4.0 cm | Maximum Tolerated Dose of Five Fraction Stereotactic Radiotherapy | 35 Gy |
| Dose Escalated 5 Fraction Stereotactic Radiosurgery - 4.1-6.0 cm | Maximum Tolerated Dose of Five Fraction Stereotactic Radiotherapy | 30 Gy |
Secondary
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.
Time frame: 1-2 years
Secondary
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.
Time frame: 1-2 years
Secondary
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.
Time frame: 1-2 years
Other Pre-specified
Feasibility of Capturing Patient Reported Outcomes Electronically Using FACT-Br Questionnaire
To assess the feasibility of capturing patient reported outcomes with the Functional Assessment of Cancer Therapy-Brain Questionnaire (FACT-Br) electronically in the Radiation Oncology clinic
Time frame: 1-2 years