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Comparing Treatments for Pelvic Bone Sarcomas

This study is comparing three treatments for pelvic bone sarcomas (cancers that start in the bone): carbon ion therapy, surgery, and proton therapy. Researchers want to see if carbon ion therapy leads to a better quality of life for patients compared to surgery, and better control of the cancer compared to proton therapy. You may be able to join if you are at least 15 years old and have a newly diagnosed pelvic bone sarcoma (like chondrosarcoma or Ewing sarcoma) that has not spread to other parts of your body. The study will look at how your quality of life changes over time and how well the treatments control the cancer for up to 5 years.

Study design
This is an observational study, meaning researchers will collect information from 72 patients who have already received one of the treatments. It is not a randomized study where treatments are assigned.
What's involved
You will complete quality of life questionnaires at the start of the study, a few months after treatment, and then once a year for up to 5 years. Your medical records will also be reviewed.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 5 years after completing their treatment to assess quality of life and cancer control.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05033288

Comparing Carbon Ion Therapy, Surgery, and Proton Therapy for Management of Pelvic Sarcomas Involving the Bone

Recruiting
Not specifiedAges 15+Observational
Mayo Clinic
~72 participants
Updated 2026-03-13 on ClinicalTrials.gov
What's tested:Electronic Health Record ReviewQuality-of-Life Assessment

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Average difference in change of functional quality of life (QOL)
Measured over Baseline (pre-treatment) to 1 year after completion of treatment
+7 more outcomes measured

Conditions

Bone Sarcoma
Chondrosarcoma
Chordoma
Ewing Sarcoma of Bone
Pelvic Rhabdomyosarcoma

Explore related trials

ChondrosarcomaChordomaEwing SarcomaOsteosarcomaRhabdomyosarcomaSoft Tissue Sarcoma

Where it's being run

3 sites across 3 states
Arizona1
Florida1
Minnesota1

Study leadership

  • Bradford S. Hoppe, MD, MPH · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Clinical Trials Referral Office
[email protected]
855-776-0015
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Average difference in change of functional quality of life (QOL)Baseline (pre-treatment) to 1 year after completion of treatment

    Will be compared between patients who received carbon ion radiation therapy (CIRT) and surgery utilizing a one-sided test for a two sample t-test for independent means. The Patient Reported Outcomes Measurement Information System (PROMIS)-29 functional score will be calculated and median, mean, and 95% confidence interval will be computed for each arm, with one-sided two-sample t-tests conducted between the surgery +/- radiation therapy (RT) and CIRT arm.

  • Proportion of patients experiencing local controlUp to 5 years after completion of treatment

    Will be calculated along with 95% confidence intervals with a one-sided test for non-inferiority to be conducted between the PT and CIRT arms.

  • Progression-free survival - local controlUp to 5 years after completion of treatment

    The Kaplan-Meier method with likelihood ratio tests will be used to calculate clinical outcomes including local control as well as progression-free survival for each arm and stratified by arm.

  • Progression-free survival - regional controlUp to 5 years after completion of treatment

    The Kaplan-Meier method with likelihood ratio tests will be used to calculate clinical outcomes including regional control as well as progression-free survival for each arm and stratified by arm.

  • Progression-free survival - distant controlUp to 5 years after completion of treatment

    The Kaplan-Meier method with likelihood ratio tests will be used to calculate clinical outcomes including distant control as well as progression-free survival for each arm and stratified by arm.

  • Overall survival - local controlUp to 5 years after completion of treatment

    The Kaplan-Meier method with likelihood ratio tests will be used to calculate clinical outcomes including local control as well as overall survival for each arm and stratified by arm.

  • Overall survival - regional controlUp to 5 years after completion of treatment

    The Kaplan-Meier method with likelihood ratio tests will be used to calculate clinical outcomes including regional control as well as overall survival for each arm and stratified by arm.

  • Overall survival - distant controlUp to 5 years after completion of treatment

    The Kaplan-Meier method with likelihood ratio tests will be used to calculate clinical outcomes including distant control as well as overall survival for each arm and stratified by arm.