Biologically-adapted, dose-escalated radiotherapy for Ewing sarcoma
Biologically-Adapted, Dose-Escalated Accelerated Radiotherapy for Ewing Sarcoma (BEAR)
NA · Mayo Clinic · NCT07188532
This trial tests whether giving higher radiotherapy doses tailored to tumor size and biology helps people aged 2 and older with Ewing sarcoma control their tumors better.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 141 (estimated) |
| Ages | 2 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic (other) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT07188532 on ClinicalTrials.gov |
What this trial studies
This approach adapts radiotherapy dose based on tumor size and tumor-specific characteristics, using higher-than-standard doses and, in some cases, hypofractionation to concentrate treatment into a shorter schedule. Treatment is delivered with modern imaging guidance and is integrated with standard chemotherapy and surgical options as clinically indicated. The protocol also collects blood and biopsy specimens for correlative research and, for a subset, genomic tumor profiling. The goal is to improve local tumor control while monitoring for side effects and feasibility in a multi-modality treatment plan.
Who should consider this trial
Good fit: Patients aged 2 years and older with histologically confirmed Ewing sarcoma (including selected Ewing-like cases treated on Ewing protocols), with performance status ≥70 and willingness to provide consent and biospecimens, are ideal candidates.
Not a fit: Patients who have prior chemotherapy or radiotherapy that would interfere with measurement of outcomes, who have poor performance status, or who cannot travel to or be treated at the study site are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this approach could improve control of the primary tumor and reduce local recurrences, which may translate into better outcomes and less need for extensive salvage surgery.
How similar studies have performed: Prior retrospective and prospective work indicates that dose-escalated and hypofractionated radiotherapy can improve local control for larger Ewing sarcoma tumors, but biologically-adapted dosing strategies are not yet widely validated.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (RECRUITING)
Study contacts
- Principal investigator: Roman O. Kowalchuk, MD — Mayo Clinic in Rochester
- Study coordinator: Clinical Trials Referral Office
- Email: mayocliniccancerstudies@mayo.edu
- Phone: 855-776-0015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Ewing Sarcoma, Round Cell Sarcoma With EWSR1-non-ETS Fusion