RecruitingNot ApplicableNCT07188532

Biologically-Adapted, Dose-Escalated Radiotherapy for the Treatment of Ewing Sarcoma, BEAR Trial

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


Sponsor

Mayo Clinic

Enrollment

141 participants

Start Date

Nov 24, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 2 Years

Inclusion Criteria5

  • 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
  • COHORT A ONLY: Willing to provide biopsy sample to run Mayo Complete Solid Tumor Panel

Exclusion Criteria9

  • 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

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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


Locations(1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

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NCT07188532


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