ClinicalTrials.gg
RecruitingNCT07188532BEARUpdated Oct 6, 2026

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

An interventional study of Biospecimen Collection and Chemotherapy in Ewing Sarcoma and Round Cell Sarcoma With EWSR1-non-ETS Fusion, sponsored by Mayo Clinic. Recruiting at 2 sites in United States. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2026-10-06.

Sponsored by Mayo Clinic · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Dec 2025; still recruiting 11 months later.
Updated Oct 6, 2026Site recruiting status changedStart date moved+3 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
170
Allocation
Non-randomized
Ages
2 Years and older
Sex
All
01

Study 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.

02

Conditions studied

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

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03

In context

Sarcoma, Ewing

250 studies on the registry are indexed under Sarcoma, Ewing; 69 are open to participants now.

This study's planned enrollment of 170 is above the median of 36 across 204 interventional studies indexed under Sarcoma, Ewing.

Browse Sarcoma, Ewing studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.

Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 performance status ≥ 70
  • Ability to provide written and complete questionnaire(s) by themselves or with assistance
  • Willing to provide blood samples for correlative research purposes
  • Willing to provide sample to run Mayo Complete Solid Tumor Panel if tumor size is >= 8 cm

Exclusion criteria

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 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 ≤ 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
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Karnofsky performance status (KPS)

A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.

Studies often ask for 60 or 70 and above. Your doctor gives the score.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
170 participants (estimated)

Study arms

  • Experimental
    Cohort A Group 1 (dose-escalated radiotherapy)

    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.

    Procedure: Biospecimen Collection · Drug: Chemotherapy · Procedure: Computed Tomography · Procedure: Conventional Radiotherapy · Procedure: Definitive Surgical Resection · Radiation: Dose-escalated Radiation Therapy · Other: Electronic Health Record Review · Radiation: Hypofractionated Radiation Therapy · Procedure: Magnetic Resonance Imaging · Procedure: Positron Emission Tomography · Other: Questionnaire Administration

  • Experimental
    Cohort A Group 2 (standard dose radiotherapy)

    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.

    Procedure: Biospecimen Collection · Drug: Chemotherapy · Procedure: Computed Tomography · Procedure: Conventional Radiotherapy · Procedure: Definitive Surgical Resection · Other: Electronic Health Record Review · Radiation: Hypofractionated Radiation Therapy · Procedure: Magnetic Resonance Imaging · Procedure: Positron Emission Tomography · Other: Questionnaire Administration · Radiation: Radiation Therapy

  • Experimental
    Cohort B (definitive radiotherapy, surgical resection)

    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.

    Procedure: Biospecimen Collection · Drug: Chemotherapy · Procedure: Computed Tomography · Procedure: Definitive Surgical Resection · Other: Electronic Health Record Review · Radiation: External Beam Radiation Therapy · Procedure: Magnetic Resonance Imaging · Procedure: Positron Emission Tomography · Other: Questionnaire Administration

  • Experimental
    Cohort C (radiotherapy, surgical resection)

    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.

    Procedure: Biospecimen Collection · Drug: Chemotherapy · Procedure: Computed Tomography · Procedure: Conventional Radiotherapy · Procedure: Definitive Surgical Resection · Other: Electronic Health Record Review · Radiation: External Beam Radiation Therapy · Radiation: Hypofractionated Radiation Therapy · Procedure: Magnetic Resonance Imaging · Procedure: Positron Emission Tomography · Other: Questionnaire Administration · Radiation: Radiation Therapy

Interventions

  • ProcedureBiospecimen Collection

    Undergo blood sample collection

    Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

  • DrugChemotherapy

    Given chemotherapy

    Also known as: Chemo, Chemotherapy (NOS), Chemotherapy, Cancer, General

  • ProcedureComputed Tomography

    Undergo CT or PET/CT

    Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, Diagnostic CAT Scan, Diagnostic CAT Scan Service Type, tomography

  • ProcedureConventional Radiotherapy

    Undergo conventional radiotherapy

    Also known as: 2-Dimensional Conventional Radiation Therapy, 2D Conventional Radiotherapy, 2D Radiotherapy, 2D-RT, Radiation, 2D Conventional

  • ProcedureDefinitive Surgical Resection

    Undergo definitive surgical resection

  • RadiationDose-escalated Radiation Therapy

    Undergo hypofractionated or conventional radiotherapy

    Also known as: Dose-escalated RT

  • OtherElectronic Health Record Review

    Ancillary studies

  • RadiationExternal Beam Radiation Therapy

    Undergo definitive radiotherapy

    Also known as: Definitive Radiation Therapy, EBRT, External Beam Radiation, External Beam Radiotherapy, External Beam Radiotherapy (conventional), External Beam RT, external radiation, External Radiation Therapy, external-beam radiation, Radiation, External Beam, Teleradiotherapy, Teletherapy, Teletherapy Radiation

  • RadiationHypofractionated Radiation Therapy

    Undergo hypofractionated radiation therapy

    Also known as: Hypofractionated, Hypofractionated Radiotherapy, hypofractionation, Radiation, Hypofractionated

  • ProcedureMagnetic Resonance Imaging

    Undergo MRI

    Also known as: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI

  • ProcedurePositron Emission Tomography

    Undergo PET/CT

    Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT

  • OtherQuestionnaire Administration

    Ancillary studies

  • RadiationRadiation Therapy

    Undergo hypofractionated or conventional standard radiotherapy

    Also known as: Cancer Radiotherapy, Energy Type, ENERGY_TYPE, Irradiate, Irradiated, Irradiation, Radiation, Radiation Therapy, NOS, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation

06

What researchers measure

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. 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

  4. 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

07

Study locations

2 of 2 sites recruiting
08

References and documents

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Started Dec 2025 (actual). Primary completion is estimated for Aug 2033, 92 months after the start.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 5, 2026: start Nov 2025 → Dec 2025, primary completion Dec 2029 → Aug 2033 and completion Dec 2029 → Aug 2033.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Sep 16, 2025
First posted
Sep 23, 2025
StartActual
Dec 5, 2025was Nov 2025
Primary completionEst.
Aug 25, 2033was Dec 2029
CompletionEst.
Aug 25, 2033was Dec 2029
Last update
Oct 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
Mayo Clinic in Arizona is now Recruiting
Oct 6, 2026
Start date
Nov 24, 2025→Dec 5, 2025
Oct 5, 2026
Primary completion
Dec 31, 2029→Aug 25, 2033
Oct 5, 2026
Study completion
Dec 31, 2029→Aug 25, 2033
Oct 5, 2026
Enrollment
141→170
Oct 5, 2026
Show all 2 updates
  1. Oct 6, 2026
    Mayo Clinic in Arizona is now Recruiting
    + 1 other change: verification date
  2. Oct 5, 2026
    Start date Nov 24, 2025→Dec 5, 2025
    Primary completion Dec 31, 2029→Aug 25, 2033
    Study completion Dec 31, 2029→Aug 25, 2033
    Enrollment 141→170
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07188532
Lead sponsor
Mayo Clinic
Responsible party
Sponsor
First posted
Sep 23, 2025
Start date
Dec 5, 2025
Primary completion
Aug 25, 2033 (estimated)
Completion
Aug 25, 2033 (estimated)
Last update
Oct 6, 2026

Study contacts

Clinical Trials Referral Office
Contact
mayocliniccancerstudies@mayo.edu
855-776-0015
Roman O. Kowalchuk, MD
principal investigator · Mayo Clinic in Rochester

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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