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

NCT03412812 | Completed Results FDA Device

• 1 other identifier: IRB-300001065
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Metastases

Keywords

Brain Metastases; Stereotactic Radiosurgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Acute Toxicity of Five Fraction Stereotactic Radiotherapy Using Adverse Event Questionnaire

  1-2 years

• Late Toxicity of Five Fraction Stereotactic Radiotherapy Using Adverse Event Questionnaire

  1-2 years

• Rate of Local Tumor Control With Five Fraction Stereotactic Radiotherapy Using Adverse Event Questionnaire

  1-2 years

Other Outcomes (1)

• Feasibility of Capturing Patient Reported Outcomes Electronically Using FACT-Br Questionnaire

  1-2 years

Study Arms (2)

2.1-4.0 cm diameter

EXPERIMENTAL

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

Radiation: 7 Gy; Radiation: 8 Gy; Radiation: 9 Gy

4.1-6.0 cm diameter

EXPERIMENTAL

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.

Radiation: 6 Gy; Radiation: 7 Gy; Radiation: 8 Gy

Interventions

6 Gy RADIATION

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.

4.1-6.0 cm diameter

7 Gy RADIATION

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.

2.1-4.0 cm diameter; 4.1-6.0 cm diameter

8 Gy RADIATION

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.

2.1-4.0 cm diameter; 4.1-6.0 cm diameter

9 Gy RADIATION

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.

2.1-4.0 cm diameter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Patients with a non-index tumor (second tumor) greater than 3 cm in diameter will be excluded.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

Hazelrig-Salter Radiation Oncology Center

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Dr. John Fiveash
• Organization: University of Alabama at Birmingham

jfiveash@uabmc.edu

205-975-0224

Study Officials

• John B Fiveash, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor - Department of Radiation Oncology

Study Record Dates

• First Submitted: December 29, 2017
• First Posted: January 26, 2018
• Study Start: July 30, 2018
• Primary Completion: January 19, 2024
• Study Completion: October 1, 2025
• Last Updated: November 4, 2025
• Results First Posted: May 16, 2025

Record last verified: 2025-10

Locations

US (1)