Comparing single-fraction SBRT to standard radiation for metastatic cancer treatment
A Phase 2 Randomized Study With a Non-randomized Cohort : Assessing Single-Fraction SBRT Versus Standard Palliative Radiation in Patients With Metastatic Disease (ASTEROID)
This study is testing whether a single session of a special type of radiation therapy can help people with metastatic cancer feel less pain and live longer compared to the usual radiation treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 1500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Roswell Park Cancer Institute Academic / other |
| Drugs / interventions | radiation |
| Locations | 3 sites (Buffalo, New York and 2 other locations) |
| Trial ID | NCT04068649 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients with pathologically confirmed metastatic malignancies experiencing symptoms that may be alleviated by radiation therapy.
Not a fit: Patients with non-metastatic cancer or those whose symptoms are not related to a site of malignant disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective and less damaging treatment option for patients with metastatic cancer.
How similar studies have performed: Other studies have shown promising results with SBRT in treating metastatic cancer, indicating that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Buffalo, New York and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.