Biologically-Adapted, Dose-Escalated Radiotherapy for the Treatment of Ewing Sarcoma, BEAR Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Biospecimen Collection, Chemotherapy, Computed Tomography, Conventional Radiotherapy.
- Who it may be relevant to
- Registry conditions: Ewing Sarcoma, Round Cell Sarcoma With EWSR1-non-ETS Fusion. Basic parameters: from 2 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Biologically-Adapted, Dose-Escalated Accelerated Radiotherapy for Ewing Sarcoma (BEAR)
Overview
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.
Interventions
- Procedure Biospecimen Collection
Undergo blood sample collection - Drug Chemotherapy
Given chemotherapy - Procedure Computed Tomography
Undergo CT or PET/CT - Procedure Conventional Radiotherapy
Undergo conventional radiotherapy - Procedure Definitive Surgical Resection
Undergo definitive surgical resection - Radiation Dose-escalated Radiation Therapy
Undergo hypofractionated or conventional radiotherapy - Other Electronic Health Record Review
Ancillary studies - Radiation External Beam Radiation Therapy
Undergo definitive radiotherapy - Radiation Hypofractionated Radiation Therapy
Undergo hypofractionated radiation therapy - Procedure Magnetic Resonance Imaging
Undergo MRI
Primary outcome measures
- Reduction in local failure for patients with large tumors (Cohort A) [Time frame: Up to 2 years]
Secondary outcome measures (4)
- Incidence of targeted, late grade 3 or greater adverse events (Cohort A) [Time frame: Up to 1 year after completion of local therapy]
- Event-free survival (Cohort A) [Time frame: Up to 1 year after completion of local therapy]
- Time to progression (Cohort A) [Time frame: Up to 1 year after completion of local therapy]
- Overall survival (Cohort A) [Time frame: Up to 1 year after completion of local therapy]
Eligibility criteria
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 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
- Willing to provide biopsy sample to run Mayo Complete Solid Tumor Panel if tumor size is >= 8 cm
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Mayo Clinic in Arizona — Phoenix
- Mayo Clinic in Rochester — Rochester
Identifiers
NCT: NCT07188532 · GMROR2411 · 24-004837 · BEAR