Ewing Sarcoma, Round Cell Sarcoma With EWSR1-non-ETS Fusion
Conditions
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.
Interventions
PROCEDUREBiospecimen Collection
Undergo blood sample collection
DRUGChemotherapy
Given chemotherapy
PROCEDUREComputed Tomography
Undergo CT or PET/CT
PROCEDUREConventional Radiotherapy
Undergo conventional radiotherapy
PROCEDUREDefinitive Surgical Resection
Undergo definitive surgical resection
RADIATIONDose-escalated Radiation Therapy
Undergo hypofractionated or conventional radiotherapy
OTHERElectronic Health Record Review
Ancillary studies
RADIATIONExternal Beam Radiation Therapy
Undergo definitive radiotherapy
RADIATIONHypofractionated Radiation Therapy
Undergo hypofractionated radiation therapy
PROCEDUREMagnetic Resonance Imaging
Undergo MRI
PROCEDUREPositron Emission Tomography
Undergo PET/CT
OTHERQuestionnaire Administration
Ancillary studies
RADIATIONRadiation Therapy
Undergo hypofractionated or conventional standard radiotherapy
Sponsors
Mayo Clinic
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
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:
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in local failure for patients with large tumors (Cohort A) | Up to 2 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of targeted, late grade 3 or greater adverse events (Cohort A) | Up to 1 year after completion of local therapy | Assessed per RECIST version 1.1. |
| Event-free survival (Cohort A) | Up to 1 year after completion of local therapy | 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 to progression (Cohort A) | Up to 1 year after completion of local therapy | Will be calculated descriptively, via frequencies and percentages at various timepoints of interest, including the 1-year local control rate. |
| Overall survival (Cohort A) | Up to 1 year after completion of local therapy | Overall survival (OS) is defined as the time from study entry to death from any cause, estimated using the Kaplan-Meier method. |
Countries
United States
Contacts
CONTACTClinical Trials Referral Office
PRINCIPAL_INVESTIGATORRoman O. Kowalchuk, MD
Mayo Clinic in Rochester
Outcome results
None listed