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

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03412812
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Alabama at Birmingham
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	John B Fiveash, MD
Principal Investigator Affiliation	University of Alabama at Birmingham
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Active, not recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Brain Metastases

Additional Details

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.

Arms & Interventions

Arms

Experimental: 2.1-4.0 cm diameter

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

Experimental: 4.1-6.0 cm diameter

Interventions

Radiation: - 6 Gy

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.

Radiation: - 7 Gy

Radiation: - 8 Gy

Radiation: - 9 Gy

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Birmingham, Alabama

Status

Address

Hazelrig-Salter Radiation Oncology Center

Birmingham, Alabama, 35233