RECRUITINGINTERVENTIONAL

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

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

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form 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 Who Should NOT Join This Trial: 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

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

PROCEDURE

Positron Emission Tomography

Undergo PET/CT

OTHER

Questionnaire Administration

Ancillary studies

RADIATION

Radiation Therapy

Undergo hypofractionated or conventional standard radiotherapy

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States