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

Mayo Clinic

Status

Enrolling

Conditions

Round Cell Sarcoma With EWSR1-non-ETS Fusion

Ewing Sarcoma

Treatments

Procedure: Magnetic Resonance Imaging

Procedure: Conventional Radiotherapy

Other: Questionnaire Administration

Radiation: Dose-escalated Radiation Therapy

Procedure: Definitive Surgical Resection

Radiation: External Beam Radiation Therapy

Procedure: Computed Tomography

Radiation: Hypofractionated Radiation Therapy

Radiation: Radiation Therapy

Procedure: Positron Emission Tomography

Other: Electronic Health Record Review

Drug: Chemotherapy

Procedure: Biospecimen Collection

Study type

Interventional

Funder types

Other

Identifiers

NCT07188532

GMROR2411 (Other Identifier)

BEAR (Other Identifier)

24-004837 (Other Identifier)

NCI-2025-06507 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment

141 estimated patients

Sex

All

Ages

2+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

PRE-REGISTRATION: 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 REGISTRATION: INCLUSION CRITERIA
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 criteria

REGISTRATION: 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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

141 participants in 4 patient groups

Cohort A Group 1 (dose-escalated radiotherapy)

Experimental group

Description:

Patients may receive SOC chemotherapy every 2 weeks for at least 3 cycles prior to radiotherapy. Patients then undergo hypofractionated or conventional dose-escalated radiotherapy daily, excluding weekends and holidays, for 25-36 treatment fractions in the absence of disease progression or unacceptable toxicity. Patients may also receive consolidation chemotherapy after completion of radiotherapy and/or surgical resection. Patients also undergo blood sample collection throughout the study. Additionally, patients may also undergo CT, PET/CT, and MRI with or without CT throughout the study at treating clinician's discretion.

Treatment:

Other: Electronic Health Record Review

Drug: Chemotherapy

Procedure: Biospecimen Collection

Procedure: Positron Emission Tomography

Radiation: Hypofractionated Radiation Therapy

Procedure: Computed Tomography

Procedure: Definitive Surgical Resection

Radiation: Dose-escalated Radiation Therapy

Other: Questionnaire Administration

Procedure: Conventional Radiotherapy

Procedure: Magnetic Resonance Imaging

Cohort A Group 2 (standard dose radiotherapy)

Experimental group

Description:

Patients may receive SOC chemotherapy every 2 weeks for at least 3 cycles prior to radiotherapy. Patients then undergo hypofractionated or conventional standard dose radiotherapy daily, excluding weekends and holidays, for 25-31 treatment fractions in the absence of disease progression or unacceptable toxicity. Patients may also receive consolidation chemotherapy after completion of radiotherapy and/or surgical resection. Patients also undergo blood sample collection throughout the study. Additionally, patients may also undergo CT, PET/CT, and MRI with or without CT throughout the study at treating clinician's discretion.

Treatment:

Other: Electronic Health Record Review

Drug: Chemotherapy

Procedure: Biospecimen Collection

Radiation: Radiation Therapy

Procedure: Positron Emission Tomography

Radiation: Hypofractionated Radiation Therapy

Procedure: Computed Tomography

Procedure: Definitive Surgical Resection

Other: Questionnaire Administration

Procedure: Conventional Radiotherapy

Procedure: Magnetic Resonance Imaging

Cohort B (definitive radiotherapy, surgical resection)

Experimental group

Description:

Patients may receive SOC chemotherapy every 2 weeks for at least 3 cycles prior to radiotherapy. Patients with tumor size \< 8cm at diagnosis undergo definitive radiotherapy or surgical resection. Patients may also receive consolidation chemotherapy after completion of definitive radiotherapy or surgical resection. Patients also undergo blood sample collection throughout the study. Additionally, patients may also undergo CT, PET/CT, and MRI with or without CT throughout the study at treating clinician's discretion.

Treatment:

Other: Electronic Health Record Review

Drug: Chemotherapy

Procedure: Biospecimen Collection

Procedure: Positron Emission Tomography

Procedure: Computed Tomography

Radiation: External Beam Radiation Therapy

Procedure: Definitive Surgical Resection

Other: Questionnaire Administration

Procedure: Magnetic Resonance Imaging

Cohort C (radiotherapy, surgical resection)

Experimental group

Description:

Patients may receive SOC chemotherapy every 2 weeks for at least 3 cycles prior to radiotherapy. Patients undergo radiotherapy before or after undergoing definitive surgical resection. Patients may also receive consolidation chemotherapy after completion of definitive radiotherapy and surgical resection. Patients also undergo blood sample collection throughout the study. Additionally, patients may also undergo CT, PET/CT, and MRI with or without CT throughout the study at treating clinician's discretion.

Treatment:

Other: Electronic Health Record Review

Drug: Chemotherapy

Procedure: Biospecimen Collection

Radiation: Radiation Therapy

Procedure: Positron Emission Tomography

Radiation: Hypofractionated Radiation Therapy

Procedure: Computed Tomography

Radiation: External Beam Radiation Therapy

Procedure: Definitive Surgical Resection

Other: Questionnaire Administration

Procedure: Conventional Radiotherapy