Hippocampal Sparing Whole Brain Radiation Versus Stereotactic Radiation in Patients With 5-20 Brain Metastases: A Phase III, Randomized Trial

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Hippocampal Sparing Whole Brain Radiation Versus Stereotactic Radiation in Patients With 5-20 Brain Metastases: A Phase III, Randomized Trial

Study Purpose

This research study is studying two different types of radiation as treatment for brain metastases (tumors in the brain that spread from a cancer that originated elsewhere in the body)

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 - 80 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Participants must have a biopsy proven solid malignancy with untreated (by radiation) intracranial lesions radiographically consistent with or pathologically proven to be brain metastases.

Patients who have undergone prior systemic therapy are eligible.

- Five-twenty intracranial lesions must be present on MRI of the brain.

- Age 18-80 years at diagnosis of brain metastases.

- Karnofsky performance status of at least 70.

Exclusion Criteria:

- Participants who have undergone prior radiation for brain metastases.

- Patients who have undergone resection of one or more brain metastases but who have not yet started adjuvant radiotherapy are eligible for the study.

- Participants who cannot undergo a brain MRI.

- Participants who cannot receive gadolinium (MRI contrast) - Participants with stage IV-V chronic kidney disease or end stage renal disease.

- Participants with widespread, definitive leptomeningeal disease.

- Participants with small cell lung cancer, lymphoma, or myeloma.

- Participants with a maximum tumor diameter exceeding 5 cm (if not resected)

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.	NCT03075072
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.	Dana-Farber Cancer Institute
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Ayal Aizer, MD MHS
Principal Investigator Affiliation	Brigham and Women's Hospital
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 research study is a Phase III clinical trial. Phase III clinical trials examine the safety and effectiveness of a treatment, often comparing it to another known treatment. In this case, the investigators are specifically looking at differences between two forms of radiation treatment in terms of subsequent quality of life. In this research study, the investigators are comparing stereotactic (focused, pinpoint) radiation (in which each tumor is narrowly targeted) against whole brain radiation (radiation targeting the entire brain) in the treatment of brain metastases. Currently whole brain radiation is the standard option for patients with 5-20 brain metastases. Stereotactic radiation is the standard option for patients with 1-4 brain metastases. Among patients with 1-4 brain metastases, recently published studies suggest that stereotactic radiation results in fewer neurologic side effects than whole brain radiation. It also yields better quality of life in this population. It remains unknown whether stereotactic radiation improves quality of life in patients with 5-20 brain metastases relative to whole brain radiation. In this study, the investigators seek to determine which of the two methods of study treatment results in a better subsequent quality of life for patients with 5-20 brain metastases.

Arms & Interventions

Arms

Active Comparator: Whole Brain Radiation

- MRI will be performed prior to radiation is administered - A hippocampal sparing approach will be used when possible - Dose will be 30 Gy in 10 fractions

Experimental: Stereotactic Radiation (SRS)

- MRI will be performed prior to radiation is administered - Radiation will be given in 1-5 fractions (dose depends on the size of the tumor that will be treated)

Interventions

Radiation: - Whole brain radiation

Treatment of the whole brain with radiation. When possible the hippocampus will be spared from radiation.

Radiation: - Stereotactic radiation (SRS)

Focused radiation to each individual brain metastasis without treatment of the remainder of the brain.

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.

Brigham and Women's Hospital, Boston, Massachusetts

Status

Address

Brigham and Women's Hospital

Boston, Massachusetts, 02115

Dana Farber Cancer Institute, Boston, Massachusetts

Status

Address

Dana Farber Cancer Institute

Boston, Massachusetts, 02116

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