RecruitingPhase 2NCT03808337

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

PROMISE-005: A Phase II Randomized Study Assessing the Efficacy of Stereotactic Body Radiotherapy (SBRT) in Patients With Oligometastatic Breast or Lung Cancer


Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

145 participants

Start Date

Jan 16, 2019

Study Type

INTERVENTIONAL

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether adding a highly targeted type of radiation called SBRT (stereotactic body radiotherapy — a very precise radiation technique that delivers high doses to specific spots) to standard cancer treatment improves outcomes for patients whose cancer has spread to a limited number of places in the body. **You may be eligible if...** - You have metastatic breast cancer (any subtype), OR - You have non-small cell lung cancer (with or without certain gene mutations) whose cancer has progressed - You have 5 or fewer separate spots where the cancer has spread, and these spots can be targeted with SBRT - Your cancer is measurable on scans - Your disease has been stable on your current treatment for at least 3 months (if already on treatment) **You may NOT be eligible if...** - You have more than 5 disease sites - Your cancer type is not one of the eligible types listed - The spots where cancer has spread cannot be safely targeted with radiation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

RADIATIONStereotactic 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.

DRUGSystemic 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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT03808337