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

Brain Metastases Clinical Trial

— RAD1705  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03412812
• Other study ID #: IRB-300001065
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 30, 2018
• Est. completion date: February 2025

Study information

• Verified date: January 2024
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 13
• Est. completion date: February 2025
• Est. primary completion date: January 19, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Metastases
• Brain Neoplasms
• Neoplasm Metastasis

Intervention

Radiation:
• Dose Escalated Five Fraction Stereotactic Radiosurgery
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.

Locations

Country	Name	City	State
United States	Hazelrig-Salter Radiation Oncology Center	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	1-2 years
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	1-2 years
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.	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.	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.	1-2 years