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



Status:Recruiting
Conditions:Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:9/2/2018
Start Date:July 30, 2018
End Date:February 2020
Contact:Valerie P Powell
Email:vpowell@uabmc.edu
Phone:205-975-9316

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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.

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.

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.
We found this trial at
1
site
Birmingham, Alabama 35249
?
mi
from
Birmingham, AL
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