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

PHASE2RecruitingINTERVENTIONAL
Enrollment

145

Participants

Timeline

Start Date

January 16, 2019

Primary Completion Date

January 31, 2026

Study Completion Date

January 31, 2026

Conditions
Triple Negative Breast CancerNon Small Cell Lung CancerMetastatic Breast CancerMetastatic Non-Small Cell Lung Carcinoma
Interventions
RADIATION

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.

DRUG

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.

Trial Locations (12)

10065

RECRUITING

Memorial Sloan Kettering Cancer Center, New York

10604

RECRUITING

Memorial Sloan Kettering Westchester, Harrison

11553

RECRUITING

Memorial Sloan Kettering Nassau, Uniondale

11725

RECRUITING

Memorial Sloan Kettering Cancer Center @ Commack, Commack

18103

RECRUITING

Lehigh Valley Health Network, Allentown

33143

RECRUITING

Baptist Alliance - McI, Miami

94070

NOT_YET_RECRUITING

Natera, Inc. (Data and Specimen Analysis Only), San Carlos

06102

RECRUITING

Hartford Healthcare, Hartford

06850

RECRUITING

WCHN Norwalk Hospital - Data Collection, Norwalk

07920

RECRUITING

Memorial Sloan Kettering Basking Ridge, Basking Ridge

07748

RECRUITING

Memorial Sloan Kettering Monmouth, Middletown

07645

RECRUITING

Memorial Sloan Kettering Bergen, Montvale

All Listed Sponsors
lead

Memorial Sloan Kettering Cancer Center

OTHER