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Comparing Radiation Therapies for Metastatic Cancer

This study is comparing two types of radiation therapy for patients with cancer that has spread (metastatic cancer). You would receive either standard palliative radiation therapy or single-fraction stereotactic body radiation therapy (SBRT). SBRT uses special equipment to deliver radiation very precisely, often in fewer treatments. The main goals are to see how these treatments affect your pain and quality of life over 12 weeks. To join, you must have metastatic cancer causing symptoms or likely to cause symptoms, and be at least 18 years old. The study aims to enroll 1500 participants, but its current recruitment status is unclear.

Study design
This is an interventional study where 1500 participants are randomly assigned to one of two treatment groups.
What's involved
You would undergo either palliative radiation therapy or single-fraction SBRT. You would also complete quality-of-life assessments and questionnaires.
Compensation
Not stated in the trial record.
Follow-up
After treatment, participants may be followed up at 5 and 12 weeks.

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NCT04068649

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Roswell Park Cancer Institute
~1,500 participants
Updated 2026-04-30 on ClinicalTrials.gov
What's tested:Palliative Radiation TherapyQuality-of-Life AssessmentQuestionnaire AdministrationStereotactic Body Radiation Therapy

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pain responses
Measured over Baseline up to 12 weeks
+1 more outcome measured

Conditions

Metastatic Malignant Neoplasm

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NCT04068649

Where you'd take part

This study runs at 3 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Good Samaritan Hospital

    West Islip, New Yorkstudy coordinator listed

    Recruiting

  • Roswell Park Cancer Institute

    Buffalo, New Yorkstudy coordinator listed

    Recruiting

  • The Cancer Institute at St. Francis Hospital

    East Hills, New Yorkstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Anurag K Singh · PRINCIPAL_INVESTIGATOR · Roswell Park Cancer Institute

Who to contact

Anurag K. Singh
[email protected]
716-845-3218
Email the study team

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Pain responsesBaseline up to 12 weeks

    Will be quantified using the pain scales from the Brief Pain Inventory (BPI). Will be an analysis-of-covariance.

  • Change in Quality of lifeBaseline up to 12 weeks

    Will be measured with European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30. Will be an analysis-of-covariance.