Biospecimen Collection
ProcedureUndergo blood sample collection
Other names: Biological Sample Collection, Biospecimen Collected, Specimen Collection
NCT Number: NCT07188532
This clinical trial evaluates the effect of radiotherapy doses based on tumor size and tumor-specific characteristics (biologically-adapted) in treating patients with Ewing sarcoma. Radiotherapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. Conventional radiotherapy uses minimal imaging support to determine the positioning of radiotherapy. Hypofractionated radiotherapy delivers higher doses of radiotherapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Dose-escalated radiotherapy uses doses that are higher than those used in conventional radiotherapy. Larger tumor sizes and other tumor-specific characteristics have been shown to be related to poorer outcomes. In addition, after dose-escalated radiotherapy, patients with larger tumors have demonstrated improved control of the disease at the primary tumor site. Giving biologically-adapted, dose-escalated radiotherapy may reduce the return of the cancer at the primary tumor site in patients with Ewing sarcoma with large tumors and other unfavorable characteristics. This clinical trial also evaluates the role of biomarkers in patients with Ewing sarcoma. Studying samples of blood and tumor tissue from patients with Ewing sarcoma in the laboratory may help doctors learn more about predicting the amount of disease and the likelihood of the cancer coming back.
Interested in participating?
Request Info2 year and older
All sexes
Interventional
Not applicable
Mayo Clinic in Arizona, Phoenix, Arizona, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Undergo blood sample collection
Other names: Biological Sample Collection, Biospecimen Collected, Specimen Collection
Given chemotherapy
Other names: Chemo, Chemotherapy (NOS), Chemotherapy, Cancer, General
Undergo CT or PET/CT
Other names: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, Diagnostic CAT Scan, Diagnostic CAT Scan Service Type, tomography
Undergo conventional radiotherapy
Other names: 2-Dimensional Conventional Radiation Therapy, 2D Conventional Radiotherapy, 2D Radiotherapy, 2D-RT, Radiation, 2D Conventional
Undergo definitive surgical resection
Undergo hypofractionated or conventional radiotherapy
Other names: Dose-escalated RT
Ancillary studies
Undergo definitive radiotherapy
Other names: Definitive Radiation Therapy, EBRT, External Beam Radiation, External Beam Radiotherapy, External Beam Radiotherapy (conventional), External Beam RT, external radiation, External Radiation Therapy, external-beam radiation, Radiation, External Beam, Teleradiotherapy, Teletherapy, Teletherapy Radiation
Undergo hypofractionated radiation therapy
Other names: Hypofractionated, Hypofractionated Radiotherapy, hypofractionation, Radiation, Hypofractionated
Undergo MRI
Other names: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI
Undergo PET/CT
Other names: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT
Ancillary studies
Undergo hypofractionated or conventional standard radiotherapy
Other names: Cancer Radiotherapy, Energy Type, ENERGY_TYPE, Irradiate, Irradiated, Irradiation, Radiation, Radiation Therapy, NOS, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation
Time frame: Up to 2 years
Large tumors defined as ≥ 8cm. Will be compared to the historical control of 14.3%. Local failure will be defined per the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Time frame: Up to 1 year after completion of local therapy
Assessed per RECIST version 1.1.
Time frame: Up to 1 year after completion of local therapy
Event-free survival (EFS) is defined as the time from study entry to any progression of disease or recurrence of disease or death from any cause, whichever occurs first.
Time frame: Up to 1 year after completion of local therapy
Will be calculated descriptively, via frequencies and percentages at various timepoints of interest, including the 1-year local control rate.
Time frame: Up to 1 year after completion of local therapy
Overall survival (OS) is defined as the time from study entry to death from any cause, estimated using the Kaplan-Meier method.
Contact information is provided by the study sponsor or research team.
Mayo Clinic
Other
Biologically-Adapted, Dose-Escalated Accelerated Radiotherapy for Ewing Sarcoma (BEAR)
Acronym: BEAR
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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