A Dose Escalation Trial of Five Fraction Stereotactic Radiation Therapy for Brain Metastases (RAD1705)

The University of Alabama at Birmingham

Status: Completed

Conditions: Brain Metastases

Treatments: Radiation: 7 Gy; Radiation: 8 Gy; Radiation: 6 Gy; Radiation: 9 Gy

Study type: Interventional

Funder types: Other

Identifiers

NCT03412812

IRB-300001065

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 2 patient groups

2.1-4.0 cm diameter

Experimental group

Description:

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

Treatment:

Radiation: 9 Gy

Radiation: 8 Gy

Radiation: 7 Gy

4.1-6.0 cm diameter

Experimental group

Description:

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.

Treatment:

Radiation: 6 Gy

Radiation: 8 Gy

Radiation: 7 Gy