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| ID | Type | Description | Link |
|---|---|---|---|
| 24-004837 | Other Identifier | Mayo Clinic Institutional Review Board | |
| BEAR | Other Identifier | Mayo Clinic Radiation Oncology |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A Group 1 (dose-escalated radiotherapy) | Experimental | Patients may receive SOC chemotherapy every 2 weeks for at least 3 cycles prior to radiotherapy. Patients then undergo hypofractionated or conventional dose-escalated radiotherapy daily, excluding weekends and holidays, for 25-36 treatment fractions in the absence of disease progression or unacceptable toxicity. Patients may also receive consolidation chemotherapy after completion of radiotherapy and/or surgical resection. Patients also undergo blood sample collection throughout the study. Additionally, patients may also undergo CT, PET/CT, and MRI with or without CT throughout the study at treating clinician's discretion. |
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| Cohort A Group 2 (standard dose radiotherapy) | Experimental | Patients may receive SOC chemotherapy every 2 weeks for at least 3 cycles prior to radiotherapy. Patients then undergo hypofractionated or conventional standard dose radiotherapy daily, excluding weekends and holidays, for 25-31 treatment fractions in the absence of disease progression or unacceptable toxicity. Patients may also receive consolidation chemotherapy after completion of radiotherapy and/or surgical resection. Patients also undergo blood sample collection throughout the study. Additionally, patients may also undergo CT, PET/CT, and MRI with or without CT throughout the study at treating clinician's discretion. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biospecimen Collection | Procedure | Undergo blood sample collection |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of targeted, late grade 3 or greater adverse events (Cohort A) | Assessed per RECIST version 1.1. | Up to 1 year after completion of local therapy |
| 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. |
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Inclusion Criteria:
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
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Referral Office | Contact | 855-776-0015 | mayocliniccancerstudies@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Roman O. Kowalchuk, MD | Mayo Clinic in Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Arizona | Not yet recruiting | Phoenix | Arizona | 85054 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| Cohort B (definitive radiotherapy, surgical resection) | Experimental | Patients may receive SOC chemotherapy every 2 weeks for at least 3 cycles prior to radiotherapy. Patients with tumor size < 8cm at diagnosis undergo definitive radiotherapy or surgical resection. Patients may also receive consolidation chemotherapy after completion of definitive radiotherapy or surgical resection. Patients also undergo blood sample collection throughout the study. Additionally, patients may also undergo CT, PET/CT, and MRI with or without CT throughout the study at treating clinician's discretion. |
|
| Cohort C (radiotherapy, surgical resection) | Experimental | Patients may receive SOC chemotherapy every 2 weeks for at least 3 cycles prior to radiotherapy. Patients undergo radiotherapy before or after undergoing definitive surgical resection. Patients may also receive consolidation chemotherapy after completion of definitive radiotherapy and surgical resection. Patients also undergo blood sample collection throughout the study. Additionally, patients may also undergo CT, PET/CT, and MRI with or without CT throughout the study at treating clinician's discretion. |
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| Chemotherapy | Drug | Given chemotherapy |
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| Computed Tomography | Procedure | Undergo CT or PET/CT |
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| Conventional Radiotherapy | Procedure | Undergo conventional radiotherapy |
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| Definitive Surgical Resection | Procedure | Undergo definitive surgical resection |
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| Dose-escalated Radiation Therapy | Radiation | Undergo hypofractionated or conventional radiotherapy |
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| Electronic Health Record Review | Other | Ancillary studies |
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| External Beam Radiation Therapy | Radiation | Undergo definitive radiotherapy |
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| Hypofractionated Radiation Therapy | Radiation | Undergo hypofractionated radiation therapy |
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| Magnetic Resonance Imaging | Procedure | Undergo MRI |
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| Positron Emission Tomography | Procedure | Undergo PET/CT |
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| Questionnaire Administration | Other | Ancillary studies |
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| Radiation Therapy | Radiation | Undergo hypofractionated or conventional standard radiotherapy |
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| Up to 1 year after completion of local therapy |
| 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. | Up to 1 year after completion of local therapy |
| 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. | Up to 1 year after completion of local therapy |
| Mayo Clinic in Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
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| ID | Term |
|---|---|
| D012512 | Sarcoma, Ewing |
| ID | Term |
|---|---|
| D012516 | Osteosarcoma |
| D018213 | Neoplasms, Bone Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D012509 | Sarcoma |
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| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D004358 | Drug Therapy |
| D011827 | Radiation |
| D003226 | Congresses as Topic |
| D000069473 | Radiation Dose Hypofractionation |
| D009682 | Magnetic Resonance Spectroscopy |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D013812 | Therapeutics |
| D055585 | Physical Phenomena |
| D009938 | Organizations |
| D004472 | Health Care Economics and Organizations |
| D019583 | Dose Fractionation, Radiation |
| D011879 | Radiotherapy Dosage |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
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