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RecruitingInterventional

Biologically-Adapted, Dose-Escalated Accelerated Radiotherapy for Ewing Sarcoma (BEAR)

NCT ID: NCT07188532Sponsor: Mayo ClinicLast updated: 2026-06-04

Summary

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.

Arms & interventions

  • ProcedureBiospecimen Collection

    Undergo blood sample collection

  • DrugChemotherapy

    Given chemotherapy

  • ProcedureComputed Tomography

    Undergo CT or PET/CT

  • ProcedureConventional Radiotherapy

    Undergo conventional radiotherapy

  • ProcedureDefinitive Surgical Resection

    Undergo definitive surgical resection

  • RadiationDose-escalated Radiation Therapy

    Undergo hypofractionated or conventional radiotherapy

  • OtherElectronic Health Record Review

    Ancillary studies

  • RadiationExternal Beam Radiation Therapy

    Undergo definitive radiotherapy

  • RadiationHypofractionated Radiation Therapy

    Undergo hypofractionated radiation therapy

  • ProcedureMagnetic Resonance Imaging

    Undergo MRI

  • ProcedurePositron Emission Tomography

    Undergo PET/CT

  • OtherQuestionnaire Administration

    Ancillary studies

  • RadiationRadiation Therapy

    Undergo hypofractionated or conventional standard radiotherapy

Outcome measures

Primary

  • Reduction 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

Secondary

  • Incidence of targeted, late grade 3 or greater adverse events (Cohort A)

    Time frame: Up to 1 year after completion of local therapy

  • Event-free survival (Cohort A)

    Time frame: Up to 1 year after completion of local therapy

  • Time to progression (Cohort A)

    Time frame: Up to 1 year after completion of local therapy

  • Overall survival (Cohort A)

    Time frame: Up to 1 year after completion of local therapy

Eligibility criteria

Sex: AllAge: 2 Years and olderHealthy volunteers: No
Inclusion Criteria: * Histological confirmation of Ewing sarcoma, including both skeletal and extra-skeletal primary tumors. Patients with "Ewing-like" sarcoma may be eligible if patients are planned to be treated per Ewing treatment paradigms, as defined in this clinical trial * Patients of age ≥ 2 years are eligible for the study * Lansky or Karnofsky performance status ≥ 70 * Ability to provide written informed consent and complete questionnaire(s) by themselves or with assistance * Willing to provide blood samples for correlative research purposes * Willing to provide biopsy sample to run Mayo Complete Solid Tumor Panel if tumor size is \>= 8 cm Exclusion Criteria: * Prior chemotherapy or radiotherapy that, in the opinion of the treating medical oncologist or radiation oncologist, is considered to interfere with the current treatment or measurement of outcomes * Receiving any investigational agent which would be considered as a treatment for the primary neoplasm that is considered by the investigator to interfere with the current treatment or measurement of outcomes * Note: Co-enrollment on another clinical trial is allowed per the treating radiation oncologist's discretion * Other active malignancy ≤ 1 year prior to registration that is considered by the investigator to interfere with the current treatment or measurement of outcomes * Patients that have severe co-morbid systemic illness or other disease which would interfere significantly with the current treatment or measurement of outcomes * Patients that have active uncontrolled systemic infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, or psychiatric illness or social situation that would limit study adherence * Any of the following: * Pregnant patients * Nursing patients

Study locations (2)

Mayo Clinic in Arizona

Phoenix, Arizona, 85054

Not Yet Recruiting
Clinical Trials Referral Office · Contact
855-776-0015mayocliniccancerstudies@mayo.edu
Safia K. Ahmed, MD · Principal Investigator

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

Recruiting
Clinical Trials Referral Office · Contact
855-776-0015mayocliniccancerstudies@mayo.edu
Roman O. Kowalchuk, MD · Principal Investigator