Comparing single-fraction SBRT to standard radiation for metastatic cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II trial evaluates the effectiveness of single-fraction stereotactic body radiation therapy (SBRT) compared to standard palliative radiation therapy in patients with metastatic cancer. The study focuses on assessing patient-reported pain response and quality of life, as well as overall survival rates between the two treatment approaches. Participants will be randomized into two groups: one receiving SBRT and the other receiving standard radiation therapy. The trial also explores various secondary objectives, including changes in immune markers, treatment-related toxicity, and cognitive function over time.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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's running

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

Study contacts

• Principal investigator: Anurag K Singh — Roswell Park Cancer Institute

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.