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

Not Applicable

Active, not recruiting

• Conditions: Brain Metastases
• Interventions: Radiation: Dose Escalated Five Fraction Stereotactic Radiosurgery

• Registration Number: NCT03412812
• Lead Sponsor: University of Alabama at Birmingham

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.

Study Timeline

• Study First Submitted: 2017-12-29
• Study First Submitted QC: 2018-01-19
• Study First Posted: 2018-01-26
• Study Start: 2018-07-30
• Status Verified: 2024-01
• Primary Completion: 2024-01-19
• Last Update Submitted: 2024-01-30
• Last Update Posted: 2024-01-31
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 13

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dose Escalated 5 Fraction Stereotactic Radiosurgery	Dose Escalated Five Fraction Stereotactic Radiosurgery	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.

Trial Locations

Locations (1)

Hazelrig-Salter Radiation Oncology Center; 🇺🇸 Birmingham, Alabama, United States