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

ConditionsEwing SarcomaRound Cell Sarcoma With EWSR1-non-ETS Fusion
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2+
SponsorMayo Clinic

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Chemotherapy

    Drug

    Given chemotherapy

  • Computed Tomography

    Procedure/Surgery

    Undergo CT or PET/CT

  • Conventional Radiotherapy

    Procedure/Surgery

    Undergo conventional radiotherapy

  • Definitive Surgical Resection

    Procedure/Surgery

    Undergo definitive surgical resection

  • Dose-escalated Radiation Therapy

    Radiation

    Undergo hypofractionated or conventional radiotherapy

  • Electronic Health Record Review

    Other intervention

    Ancillary studies

  • External Beam Radiation Therapy

    Radiation

    Undergo definitive radiotherapy

  • Hypofractionated Radiation Therapy

    Radiation

    Undergo hypofractionated radiation therapy

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo MRI

  • Positron Emission Tomography

    Procedure/Surgery

    Undergo PET/CT

  • Questionnaire Administration

    Other intervention

    Ancillary studies

  • Radiation Therapy

    Radiation

    Undergo hypofractionated or conventional standard radiotherapy

Treatment groups

170 Participants
are divided into 4 treatment groups
Group A: Cohort A Group 1 (dose-escalated radiotherapy)Experimental treatment 11 interventions
Group B: Cohort A Group 2 (standard dose radiotherapy)Experimental treatment 11 interventions
Group C: Cohort B (definitive radiotherapy, surgical resection)Experimental treatment 9 interventions
Group D: Cohort C (radiotherapy, surgical resection)Experimental treatment 12 interventions

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov
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