Comparing carbon ion therapy, surgery, and proton therapy for pelvic bone sarcomas
Official title: Prospective Comparative Effectiveness Trial of Carbon Ion Therapy, Surgery, and Proton Therapy for the Management of Pelvic Sarcomas (Soft Tissue/Bone) Involving the Bone
Run by Mayo Clinic · NCT05033288 · Data updated 2026-11-12
This study is testing whether carbon ion therapy works better than surgery or proton therapy for treating pelvic bone sarcomas and how these treatments affect patients' quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 15 Years and up |
| Sex | All |
| Enrollment | 72 (estimated) |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | Chemotherapy, radiation |
| Locations | 3 sites (Scottsdale, Arizona and 2 other locations) |
| Status | Recruiting |
| Started | January 20, 2022 |
| Main results expected | August 30, 2027 |
| Study ends | August 30, 2031 |
| Registry record updated | March 13, 2026 |
| Trial ID | NCT05033288 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are males and females aged 15 and older with newly diagnosed pelvic bone sarcomas and no evidence of distant metastases.
✕Probably not a fit
Patients receiving palliative treatment or those with recurrent disease may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effectiveness of carbon ion therapy compared to surgery and proton therapy in managing pelvic bone sarcomas. It aims to determine which treatment offers better disease control and fewer side effects, focusing on patient-reported health-related quality of life outcomes. Patients will complete quality of life questionnaires at various intervals, and their medical records will be reviewed to assess treatment impacts over time. The study includes patients aged 15 and older with newly diagnosed sarcomas involving the bone.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options and quality of life for patients with pelvic bone sarcomas.
How similar studies have gone: While carbon ion therapy is a novel approach, similar studies have shown promising results in other cancer types, suggesting potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Males and females \>= 15 years of age * Newly diagnosed, histologic confirmation of pelvic chordoma, chondrosarcoma, osteosarcoma, Ewing sarcoma with bone involvement, rhabdomyosarcoma (RMS) with bone involvement or non-RMS soft tissue sarcoma with bone involvement * No evidence of distant sarcoma metastases as determined by clinical examination and any form of imaging * Eastern Cooperative Oncology Group (ECOG) performance status (PS) =\< 2 * Patients capable of childbearing must agree to use adequate contraception * Ability to complete questionnaire(s) by themselves or with assistance * Ability to provide written informed consent * Chemotherapy per institutional guidelines is allowed Exclusion Criteria: * Patients receiving palliative treatment * Recurrent disease * Males and females \< 15 years of age * Previous radiation therapy to the site of the sarcoma or area surrounding it such that it would be partially or completely encompassed by the radiation volume needed to treat the current sarcoma. In other words, treatment on this study would require re-irradiation of tissues * Patients with distant sarcoma metastases * Benign pelvic bone histologies * Any of the following: * Pregnant women * Nursing women * Men or women of childbearing potential who are unwilling to employ adequate contraception
Where it's running
-
Mayo Clinic in Arizona
Scottsdale, Arizona, United States Recruiting -
Mayo Clinic in Florida
Jacksonville, Florida, United States Recruiting -
Mayo Clinic in Rochester
Rochester, Minnesota, United States Recruiting
Study contacts
- Principal investigator: Bradford S. Hoppe, MD, MPH — Mayo Clinic
- Study coordinator: Clinical Trials Referral Office
- Email: mayocliniccancerstudies@mayo.edu
- Phone: 855-776-0015
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.