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Compares treatment options for Metastatic Malignant Neoplasm
Official title Single-Fraction SBRT Versus Standard Palliative Radiation Therapy in Treating Patients With Metastatic Cancer
ClinicalTrials.gov ID: NCT04068649
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- Participants with synchronous primary malignancies must have either: 1) documented control of their second malignancy or 2) have pathological...
You likely can't join 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...
- 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...
- Participants who require or are being planned for surgical stabilization or metastasectomy of the planned radiation site
- Severe, active co-morbidity defined as follows:
See the full eligibility 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Buffalo, New York, United States
- East Hills, New York, United States
- West Islip, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Buffalo, New York, United States; East Hills, New York, United States; West Islip, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.