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Investigating the Effectiveness of Stereotactic Body Radiotherapy (SBRT) in Addition to Standard of Care Treatment for Cancer That Has Spread Beyond the Original Site of Disease
Sponsor: Memorial Sloan Kettering Cancer Center
Summary
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.
Official title: PROMISE-005: A Phase II Randomized Study Assessing the Efficacy of Stereotactic Body Radiotherapy (SBRT) in Patients With Oligometastatic Breast or Lung Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
145
Start Date
2019-01-16
Completion Date
2027-01
Last Updated
2026-02-27
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (12)
Natera, Inc. (Data and Specimen Analysis Only)
San Carlos, California, United States
Hartford Healthcare
Hartford, Connecticut, United States
WCHN Norwalk Hospital - Data Collection
Norwalk, Connecticut, United States
Baptist Alliance - McI
Miami, Florida, United States
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen
Montvale, New Jersey, United States
Memorial Sloan Kettering Cancer Center @ Commack
Commack, New York, United States
Memorial Sloan Kettering Westchester
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Memorial Sloan Kettering Nassau
Uniondale, New York, United States
Lehigh Valley Health Network
Allentown, Pennsylvania, United States