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

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.

Conditions

• Ewing Sarcoma
• Round Cell Sarcoma With EWSR1-non-ETS Fusion

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

DRUG

Chemotherapy

Given chemotherapy

PROCEDURE

Computed Tomography

Undergo CT or PET/CT

PROCEDURE

Conventional Radiotherapy

Undergo conventional radiotherapy

PROCEDURE

Definitive Surgical Resection

Undergo definitive surgical resection

RADIATION

Dose-escalated Radiation Therapy

Undergo hypofractionated or conventional radiotherapy

OTHER

Electronic Health Record Review

Ancillary studies

RADIATION

External Beam Radiation Therapy

Undergo definitive radiotherapy

RADIATION

Hypofractionated Radiation Therapy

Undergo hypofractionated radiation therapy

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

PROCEDURE

Positron Emission Tomography

Undergo PET/CT

OTHER

Questionnaire Administration

Ancillary studies

RADIATION

Radiation Therapy

Undergo hypofractionated or conventional standard radiotherapy

Sponsors & Collaborators

• Mayo Clinic

  lead OTHER

Principal Investigators

• Roman O. Kowalchuk, MD · Mayo Clinic in Rochester

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

2 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-11-24

Primary Completion

2029-12-31

Completion

2029-12-31

FDA Device

Yes

Countries

• United States

Study Locations