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NCT Number: NCT03412812

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hazelrig-Salter Radiation Oncology Center

Birmingham, Alabama, 35233, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

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.

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.

Primary outcomes

  1. Maximum Tolerated Dose of Five Fraction Stereotactic Radiotherapy

    Time frame: 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 outcomes

  1. Acute Toxicity of Five Fraction Stereotactic Radiotherapy Using Adverse Event Questionnaire

    Time frame: 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.

  2. Late Toxicity of Five Fraction Stereotactic Radiotherapy Using Adverse Event Questionnaire

    Time frame: 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.

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

    Time frame: 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.

Other outcomes

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

    Time frame: 1-2 years

    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

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

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

Acronym: RAD1705

Important dates

Study start
2018
Primary completion
2024
Study completion
2025
First posted
Jan 26, 2018
Registry last updated
Nov 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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