Breast Cancer Clinical Trial

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

Summary

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)

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Full Description

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.

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Eligibility 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)

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

196

Study ID:

NCT03075072

Recruitment Status:

Recruiting

Sponsor:

Dana-Farber Cancer Institute

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There are 2 Locations for this study

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Brigham and Women's Hospital
Boston Massachusetts, 02115, United States More Info
Ayal Aizer, MD MHS
Contact
617-732-7560
[email protected]
Ayal Aizer, MD MHS
Principal Investigator
Dana Farber Cancer Institute
Boston Massachusetts, 02116, United States More Info
Ayal Aizer, MD
Contact
617-732-7560
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

196

Study ID:

NCT03075072

Recruitment Status:

Recruiting

Sponsor:


Dana-Farber Cancer Institute

How clear is this clinincal trial information?

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