145
Participants
Start Date
January 16, 2019
Primary Completion Date
January 31, 2026
Study Completion Date
January 31, 2026
Stereotactic Body Radiotherapy/SBRT
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.
Systemic Therapy/Standard of Care
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.
RECRUITING
Memorial Sloan Kettering Cancer Center, New York
RECRUITING
Memorial Sloan Kettering Westchester, Harrison
RECRUITING
Memorial Sloan Kettering Nassau, Uniondale
RECRUITING
Memorial Sloan Kettering Cancer Center @ Commack, Commack
RECRUITING
Lehigh Valley Health Network, Allentown
RECRUITING
Baptist Alliance - McI, Miami
NOT_YET_RECRUITING
Natera, Inc. (Data and Specimen Analysis Only), San Carlos
RECRUITING
Hartford Healthcare, Hartford
RECRUITING
WCHN Norwalk Hospital - Data Collection, Norwalk
RECRUITING
Memorial Sloan Kettering Basking Ridge, Basking Ridge
RECRUITING
Memorial Sloan Kettering Monmouth, Middletown
RECRUITING
Memorial Sloan Kettering Bergen, Montvale
Memorial Sloan Kettering Cancer Center
OTHER