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RECRUITING
NCT03808337
PHASE2

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

View on ClinicalTrials.gov

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

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.

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