NCT05033288 · Mayo Clinic
Comparing Carbon Ion Therapy, Surgery, and Proton Therapy for Management of Pelvic Sarcomas Involving the Bone
What this study is about
This study compares carbon ion therapy, surgery, and proton therapy to determine if one has better disease control and fewer side effects. There are three types of radiation treatment used for pelvic bone sarcomas: surgery with or without photon/proton therapy, proton therapy alone, and carbon ion therapy alone.
View original scientific description
This study compares carbon ion therapy, surgery, and proton therapy to determine if one has better disease control and fewer side effects. There are three types of radiation treatment used for pelvic bone sarcomas: surgery with or without photon/proton therapy, proton therapy alone, and carbon ion therapy alone. The purpose of this study is to compare quality of life among patients treated for pelvic bone sarcomas across the world, and to determine if carbon ion therapy improves quality of life compared to surgery and disease control compared with proton therapy.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Scottsdale, Arizona
- Jacksonville, Florida
- Rochester, Minnesota
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 13, 2026 · Source of record for eligibility and locations