Status:
RECRUITING
Single-Fraction SBRT Versus Standard Palliative Radiation Therapy in Treating Patients With Metastatic Cancer
Lead Sponsor:
Roswell Park Cancer Institute
Conditions:
Metastatic Malignant Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 ot...
Detailed Description
PRIMARY OBJECTIVES: I. To assess patient-reported pain response and quality of life (QoL) in patients randomized to either single-fraction stereotactic body radiation therapy (SBRT) or non-SBRT palli...
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
Key Trial Info
Start Date :
November 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 18 2027
Estimated Enrollment :
1500 Patients enrolled
Trial Details
Trial ID
NCT04068649
Start Date
November 18 2019
End Date
November 18 2027
Last Update
April 25 2025
Active Locations (3)
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1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
2
The Cancer Institute at St. Francis Hospital
East Hills, New York, United States, 11548
3
Good Samaritan Hospital
West Islip, New York, United States, 11795