This study is being done to determine if stereotactic body radiotherapy (SBRT) when delivered to all sites of disease in participants with 1-5 metastases will increase the length of time before participants' disease gets worse.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
145
Radiation to each metastatic site should be delivered to a minimum dose of 30 Gy in 5 fractions (BED of 48 Gy10). The exact dose of radiotherapy will be determined by the treating radiation oncologist. Preferred regimens for lung metastases include 50 Gy in five fractions, 48 Gy in four fractions, or 54 Gy in three fractions, although lower doses may be employed to respect dose limits to critical structures such as the esophagus. Recommended SBRT dosing for other sites includes 27 to 30 Gy in three fractions or 24 Gy in one fraction for bone metastases.
Standard of care systemic therapy, including chemotherapeutics, targeted therapies, immunomodulatory agents, and hormonal therapies will be delivered at the discretion of the treating oncologist. For patients randomized to receive SBRT, systemic therapy can be continued during SBRT at the discretion and concensus of treating physicians (medical oncologist and radiation oncologist). If the treating physicians recommend discontinuing systemic therapy during SBRT, general guidelines for stopping and reinitiating systemic regimen are as follows: Hormonal therapies and immunotherapy can be continued during SBRT. Consideration can be given to holding cytotoxic chemotherapy beginning 3 to 7 days prior to the initiation of SBRT until 3 to 7 days after the completion of SBRT. Similarly, consideration can be given to holding biologic agents during SBRT and for 0 to 3 days before and after.
Natera, Inc. (Data and Specimen Analysis Only)
San Carlos, California, United States
NOT_YET_RECRUITINGHartford Healthcare
Hartford, Connecticut, United States
RECRUITINGWCHN Norwalk Hospital - Data Collection
Norwalk, Connecticut, United States
RECRUITINGBaptist Alliance - McI
Miami, Florida, United States
RECRUITINGMemorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States
RECRUITINGMemorial Sloan Kettering Monmouth
Middletown, New Jersey, United States
RECRUITINGMemorial Sloan Kettering Bergen
Montvale, New Jersey, United States
RECRUITINGMemorial Sloan Kettering Cancer Center @ Commack
Commack, New York, United States
RECRUITINGMemorial Sloan Kettering Westchester
Harrison, New York, United States
RECRUITINGMemorial Sloan Kettering Cancer Center
New York, New York, United States
RECRUITING...and 2 more locations
Progression Free Survival
To determine whether stereotactic body radiotherapy to all sites of metastatic disease in patients with oligometastatic non-small cell lung cancer or triple-negative breast cancer improves progression free survival (PFS), defined as time from randomization to disease progression or death, as compared to standard of care therapy alone.
Time frame: Up to 2 years
Overall Survival
To compare overall survival (OS) between standard of care and SBRT arms.
Time frame: Up to 2 years
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