A Dose Escalation Trial of Five Fraction Stereotactic Radiation Therapy for Brain Metastases

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase I Dose Escalation Trial of Five Fraction Stereotactic Radiation Therapy for Brain

Conditions
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Brain Metastases

Intervention / Treatment
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* Radiation: Dose Escalated Five Fraction Stereotactic Radiosurgery


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose Escalated 5 Fraction Stereotactic Radiosurgery<br>Patients will undergo dose escalated five fraction stereotactic radiosurgery for diagnosed brain metastases. Tumors must fall into one of two categories: 2.1-4.0cm diameter or 4.1-6.0 cm diameter. 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. | Radiation: Dose Escalated Five Fraction Stereotactic Radiosurgery<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 1-2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 1-2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Brain Metastases, Stereotactic Radiosurgery