Clinical trial Recruiting at 3 sites Observational Ages 15 and up

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 typeObservational
Ages15 Years and up
SexAll
Enrollment72 (estimated)
SponsorMayo Clinic
Academic / other
Drugs / interventionsChemotherapy, radiation
Locations3 sites (Scottsdale, Arizona and 2 other locations)
StatusRecruiting
StartedJanuary 20, 2022
Main results expectedAugust 30, 2027
Study endsAugust 30, 2031
Registry record updatedMarch 13, 2026
Trial IDNCT05033288 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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  • Proton therapy for chordomas and chondrosarcomas at the skull base

    This study is testing a new type of proton therapy to see if it can effectively treat chordomas and chondrosarcomas at the base of the skull while keeping side effects low and improving patients' quality of life.

    Recruiting Quironsalud · Madrid, Madrid · NCT05861245

  • Using imaging to improve proton therapy for chordomas and chondrosarcomas

    This study is testing if using advanced imaging techniques can help improve proton therapy for patients with aggressive bone tumors called chordomas and chondrosarcomas by better targeting the tumors and protecting healthy tissue.

    Recruiting at 2 sites Leiden University Medical Center · Delft, South Holland and 1 other locations · NCT04832620

  • Using Regorafenib to Maintain Treatment Benefits After Initial Therapy for Bone Sarcomas

    This study is testing if the drug regorafenib can help people with bone sarcomas stay cancer-free longer after their initial treatment.

    Recruiting at 12 sites Centre Leon Berard · Besançon and 15 other locations · NCT04055220

  • Evaluating recovery and function after bone cancer surgery

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    Recruiting at 5 sites Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 4 other locations · NCT03442465

  • AYA Sarcoma Survivors: Personalized Exercise Program Pilot

    This pilot tests a personalized 12-week exercise program for adolescents and young adults with sarcoma to see if a triage tool can connect them with the right rehabilitation and exercise services.

    Recruiting at 3 sites Dana-Farber Cancer Institute · Boston, Massachusetts and 2 other locations · NCT07662239

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.