NCT07188532 Biologically-Adapted, Dose-Escalated Radiotherapy for the Treatment of Ewing Sarcoma, BEAR Trial
| NCT ID | NCT07188532 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mayo Clinic |
| Condition | Ewing Sarcoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 141 participants |
| Start Date | 2025-11-24 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 141 participants in total. It began in 2025-11-24 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Roman O. Kowalchuk, MD
PRINCIPAL INVESTIGATOR
Mayo Clinic in Rochester
Frequently Asked Questions
Who can join the NCT07188532 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, studying Ewing Sarcoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07188532 currently recruiting?
Yes, NCT07188532 is actively recruiting participants. Contact the research team at mayocliniccancerstudies@mayo.edu for enrollment information.
Where is the NCT07188532 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT07188532 clinical trial?
NCT07188532 is sponsored by Mayo Clinic. The principal investigator is Roman O. Kowalchuk, MD at Mayo Clinic in Rochester. The trial plans to enroll 141 participants.