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

Launched by ROSWELL PARK CANCER INSTITUTE · Aug 22, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a type of radiation therapy called single-fraction stereotactic body radiation therapy (SBRT) to see how well it works for patients with metastatic cancer, which means cancer that has spread to other parts of the body. The trial is comparing this newer method to standard radiation therapy. SBRT is designed to deliver high doses of radiation to tumors very precisely, which can kill cancer cells while minimizing damage to nearby healthy tissues. The trial is currently recruiting participants aged 65 to 74 who have been diagnosed with metastatic cancer that is causing symptoms.

To join the study, participants must have a confirmed diagnosis of cancer that has spread and need radiation therapy for symptom relief. They should also be able to follow the study requirements and understand that they are part of a research trial. Those who have had previous radiation treatment in the same area or have certain health conditions may not be eligible. Participants in the trial can expect to receive either the SBRT or standard radiation treatment, along with assessments before and after the treatment to help researchers understand how well each method works.

Gender

ALL

Eligibility 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