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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
141
Undergo blood sample collection
Given chemotherapy
Undergo CT or PET/CT
Undergo conventional radiotherapy
Undergo definitive surgical resection
Undergo hypofractionated or conventional radiotherapy
Ancillary studies
Undergo definitive radiotherapy
Undergo hypofractionated radiation therapy
Undergo MRI
Undergo PET/CT
Ancillary studies
Undergo hypofractionated or conventional standard radiotherapy
Mayo Clinic in Rochester
Rochester, Minnesota, United States
RECRUITINGReduction in local failure for patients with large tumors (Cohort A)
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 2 years
Incidence of targeted, late grade 3 or greater adverse events (Cohort A)
Assessed per RECIST version 1.1.
Time frame: Up to 1 year after completion of local therapy
Event-free survival (Cohort A)
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
Time to progression (Cohort A)
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 (Cohort A)
Overall survival (OS) is defined as the time from study entry to death from any cause, estimated using the Kaplan-Meier method.
Time frame: Up to 1 year after completion of local therapy
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