Single-Fraction SBRT Versus Standard Palliative Radiation Therapy in Treating Patients With Metastatic Cancer

Recruiting now · Phase 2

Conditions studied: Metastatic Malignant Neoplasm

In brief

This phase II trial studies how well single-fraction stereotactic body radiation therapy (SBRT) works when compared to standard radiation therapy in treating patients with cancer that has spread to other places in the body (metastatic). Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue.

Key facts

Study ID

NCT04068649

Run by

Roswell Park Cancer Institute

People needed

1500

Starts

2019-11-18

Expected to finish

2027-11-18

Last updated by the study team

2026-04-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Pathologically confirmed malignancy
• Clinical or pathologic evidence of metastatic disease
• A site of malignant disease causing symptoms, or for which symptoms are imminent, in which radiation may be used for relief or prophylaxis
• Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
• Participants with synchronous primary malignancies must have either: 1) documented control of their second malignancy or 2) have pathological confirmation of the metastatic lesion/disease site being targeted
• Participant must be willing and able to participate in protocol requirements, including pre- and post-treatment survey evaluations and clinical assessments
• Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

You may not qualify if…

• Prior radiation therapy targeting the same area for which radiation treatment is being planned (i.e., re-irradiation to a specific site of metastatic disease)
• Participants with known brain metastases
• Pregnant or nursing female participants
• Participants who are unable to accurately or reliably recount their pain medication regimens, including type, amount, or frequency of pain medication usage
• Participants who require or are being planned for surgical stabilization or metastasectomy of the planned radiation site
• Severe, active co-morbidity defined as follows:
• Unstable angina and/or congestive heart failure requiring hospitalization within the last 3 months;
• Transmural myocardial infarction within the last 3 months;
• Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration;
• Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
• Unwilling or unable to follow protocol requirements
• Any condition which, in the investigator?s opinion, deems the patient unable to participate in enrollment
• Adults unable to consent
• Individuals who are not yet adults (infants, children, teenagers)
• Pregnant women
• Prisoners

Where it is running

• Roswell Park Cancer Institute — Buffalo, New York, United States (enrolling)
• The Cancer Institute at St. Francis Hospital — East Hills, New York, United States (enrolling)
• Good Samaritan Hospital — West Islip, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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