Dose-Escalated Radiotherapy for Ewing Sarcoma

(BEAR Trial)

Overseen By Clinical Trials Referral Office

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: Investigational agents

Disqualifiers: Active malignancy, Severe illness, Infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether higher doses of radiotherapy, tailored to tumor size and characteristics, can more effectively treat Ewing sarcoma, a type of cancer. Radiotherapy uses high-energy rays to kill cancer cells, and the trial examines if larger doses over shorter periods yield better results. It also analyzes blood and tumor samples to identify biomarkers that might predict cancer recurrence. Individuals with Ewing sarcoma, particularly those with larger tumors, may be suitable candidates for this study. As an unphased trial, this study provides a unique opportunity to contribute to cutting-edge research that could enhance future treatment strategies.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you are on chemotherapy, radiotherapy, or investigational agents that might interfere with the trial treatment, you may need to stop those. It's best to discuss your specific medications with the trial team.

What prior data suggests that dose-escalated radiotherapy is safe for treating Ewing sarcoma?

Research has shown that increasing the dose of radiation therapy can safely treat Ewing sarcoma, particularly in larger tumors. Studies have found that higher radiation doses can reduce the likelihood of cancer returning to the same location. Several studies have tested this method, yielding promising results in disease control.

Radiation therapy is generally well-tolerated, but it can have side effects, such as skin irritation and fatigue, similar to a sunburn or feeling worn out after a long day. However, side effects can vary among individuals. Researchers closely monitor patient responses to ensure the treatment's effectiveness and safety.

Although this specific trial lacks a phase designation, ongoing research and previous studies indicate that the treatment is under careful observation for safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the dose-escalated radiotherapy for Ewing Sarcoma because it offers a potential advancement over traditional treatment approaches. Unlike standard chemotherapy and radiotherapy, this study explores varying intensities of radiotherapy, potentially allowing for more personalized treatments. By escalating the dose and using hypofractionated schedules, there's hope for more effective tumor control with fewer side effects. This approach could lead to improved outcomes for patients, particularly when combined with surgical resection and chemotherapy, offering a more comprehensive attack on the cancer cells.

What evidence suggests that this trial's radiotherapy treatments could be effective for Ewing sarcoma?

This trial will compare different radiotherapy approaches for Ewing sarcoma. Studies have shown that higher doses of radiation can effectively treat Ewing sarcoma, especially in larger tumors. Research indicates that increasing the radiation dose can reduce the risk of cancer returning in the same area. In children and young adults with Ewing sarcoma, this approach has controlled the disease locally, preventing the tumor from regrowing where treated. Patients have reported good results with this method and have experienced manageable side effects. Overall, using higher doses of radiation may improve outcomes for those with Ewing sarcoma. Participants in this trial may receive dose-escalated radiotherapy, standard dose radiotherapy, or a combination of radiotherapy and surgical resection, depending on their assigned cohort. ^{1 2 3 6 7}

Who Is on the Research Team?

Roman O. Kowalchuk, MD

Principal Investigator

Mayo Clinic in Rochester

Are You a Good Fit for This Trial?

This trial is for patients with Ewing sarcoma, a type of bone cancer. It's specifically aimed at those who may benefit from higher doses of radiotherapy tailored to their tumor size and characteristics. Participants should be eligible for radiation treatment and have measurable disease.

Inclusion Criteria

Willing to provide blood samples for correlative research purposes

I am mostly able to care for myself and do normal activities.

Ability to provide written informed consent and complete questionnaire(s) by themselves or with assistance

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

Co-enrollment on another clinical trial is allowed per the treating radiation oncologist's discretion

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Chemotherapy

Participants receive SOC chemotherapy every 2 weeks for at least 3 cycles prior to radiotherapy

6 weeks

Radiotherapy

Participants undergo hypofractionated or conventional dose-escalated radiotherapy daily, excluding weekends and holidays, for 25-36 treatment fractions

5-7 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

• Dose-escalated Radiation Therapy
• External Beam Radiation Therapy
• Hypofractionated Radiation Therapy

Trial Overview The BEAR Trial tests if biologically-adapted, dose-escalated radiotherapy can better control Ewing sarcoma compared to conventional methods. It involves using advanced imaging like MRI and PET scans to tailor the radiation dose more precisely to the tumor's specifics.

How Is the Trial Designed?

Group I: Cohort C (radiotherapy, surgical resection) Experimental Treatment 12 Interventions

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.

Group II: Cohort B (definitive radiotherapy, surgical resection) Experimental Treatment 9 Interventions

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.

Group III: Cohort A Group 2 (standard dose radiotherapy) Experimental Treatment 11 Interventions

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.

Group IV: Cohort A Group 1 (dose-escalated radiotherapy) Experimental Treatment 11 Interventions

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.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12272112/

Definitive Radiation Therapy for Ewing Sarcoma Dose escalation for definitive radiation therapy (DE-RT) in larger Ewing sarcomas (ESs) is associated with a lower risk of local recurrence.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0360301622003376

Radiation Therapy Dose Escalation in Unresectable Ewing ... This is the only randomized trial evaluating the effect of RT dose escalation in unresectable ES/PNET, which showed excellent LC in these aggressive tumors.

3. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/full/10.1002/cncr.35196

Radiation therapy dose escalation achieves high rates of local ... Dose-escalated radiation therapy in children and young adult patients with Ewing sarcoma improves local control rates.

4. advancesradonc.com advancesradonc.com/article/S2452-1094(23)00098-2/fulltext

Effect of Radiotherapy Dose on Outcome in Nonmetastatic ... The overall survival (OS) rate for patients without metastases is between 65% and 75%, and for patients with metastases the 5-year survival rate is ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38271232/

Radiation therapy dose escalation achieves high rates of local ... Radiation therapy dose escalation achieves high rates of local control with tolerable toxicity profile in pediatric and young adult patients ...

6. advancesradonc.com advancesradonc.com/article/S2452-1094(22)00020-3/fulltext

Hypofractionated Radiation Therapy for Unresectable or ... Our study demonstrates that HFRT is an effective treatment strategy for patients with unresectable or metastatic sarcoma as it can provide ...

7. withpower.com withpower.com/trial/phase-sarcoma-ewing-9-2025-bfa88

Dose-Escalated Radiotherapy for Ewing Sarcoma ... This clinical trial evaluates the effect of radiotherapy doses based on tumor size and tumor-specific characteristics (biologically-adapted) ...