Actively Recruiting

Phase Not Applicable
Age: 2Years +
All Genders
ID07188532

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

Led by Mayo Clinic · Updated on 2026-06-04

141

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the use of biologically-adapted, dose-escalated radiotherapy based on tumor size and specific tumor characteristics in patients with Ewing sarcoma. This cancer treatment study explores how higher doses of radiotherapy, delivered over shorter periods (hypofractionated), might better control the disease at the primary tumor site, especially in patients with larger tumors. The trial also studies the role of biomarkers by analyzing blood and tumor samples to predict disease status and cancer recurrence. Patients may receive standard chemotherapy every two weeks for at least three cycles before starting radiotherapy. Depending on tumor size and characteristics, participants receive either hypofractionated or conventional dose-escalated radiotherapy, or standard radiotherapy, delivered daily except weekends and holidays, with 25 to 36 treatment sessions. Some patients may undergo definitive surgical tumor removal and consolidation chemotherapy after radiotherapy. Blood samples and imaging tests such as CT, PET/CT, and MRI are collected throughout the study. During the trial, participants undergo regular assessments including blood sample collection and various imaging scans to monitor disease progression and treatment effects. Researchers measure outcomes such as reduction in local tumor failure for large tumors over up to two years, and track adverse events, event-free survival, time to progression, and overall survival for up to one year after local therapy. The study involves ongoing monitoring of health status and disease control during and after treatment.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 2Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histological confirmation of Ewing sarcoma or Ewing-like sarcoma treated per Ewing treatment paradigms
  • Age 2 years or older
  • Lansky or Karnofsky performance status of 70 or higher
  • Ability to provide written informed consent and complete questionnaires with or without assistance
  • Willingness to provide blood samples for research
  • Willingness to provide biopsy sample if tumor size is 8 cm or larger
Not Eligible

You will not qualify if you...

  • Prior chemotherapy or radiotherapy that interferes with current treatment or outcome measurement
  • Use of investigational agents that interfere with current treatment or outcome measurement
  • Active malignancy within 1 year prior to registration interfering with treatment or outcomes
  • Severe co-morbid systemic illness or other diseases interfering with treatment or outcomes
  • Active uncontrolled systemic infection, symptomatic heart failure, unstable angina, cardiac arrhythmia, psychiatric illness, or social situations limiting adherence
  • Pregnancy or nursing

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Variable treatment duration depending on chemotherapy cycles, radiotherapy fractions, and surgery timing

Participants receive chemotherapy every 2 weeks for at least 3 cycles prior to radiotherapy. They then undergo hypofractionated or conventional dose-escalated or standard radiotherapy daily, excluding weekends and holidays, for 25 to 36 treatment fractions depending on the cohort, in the absence of disease progression or unacceptable toxicity. Participants may also undergo definitive surgical resection depending on cohort assignment. Consolidation chemotherapy may be given after completion of radiotherapy and/or surgery. Blood samples are collected throughout treatment. Imaging such as CT, PET/CT, and MRI may be performed at the treating clinician’s discretion.

Chemotherapy visits every 2 weeks for at least 3 cycles; daily radiotherapy visits excluding weekends and holidays for up to 7 weeks; additional visits for surgery and consolidation chemotherapy as applicable

Follow-up

Duration - Up to 1 year after completion of local therapy

After completing local therapy, participants are monitored for up to 1 year to assess safety, event-free survival, time to progression, and overall survival. Blood samples and imaging may continue as clinically indicated.

Periodic visits as scheduled by the study team

Trial Site Locations

Total: 2 locations

1

Mayo Clinic in Arizona

Phoenix, Arizona, United States, 85054

Not Yet Recruiting

2

Mayo Clinic in Rochester

Rochester, Minnesota, United States, 55905

Actively Recruiting

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Research Team

C

Clinical Trials Referral Office

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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