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

RecruitingObservational study

Prospective Comparative Effectiveness Trial of Carbon Ion Therapy, Surgery, and Proton Therapy for the Management of Pelvic Sarcomas (Soft Tissue/Bone) Involving the Bone

Who can join

Ages 15 and older · All sexes

Full eligibility 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

About the study

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.

What is being tested

Sponsor: Mayo Clinic · Participants: 72 · Started: Jan 20, 2022

Contact the study team

Official record on ClinicalTrials.gov — NCT05033288

Locations in the U.S.

ArizonaMayo Clinic in Arizona, Scottsdale
FloridaMayo Clinic in Florida, Jacksonville
MinnesotaMayo Clinic in Rochester, Rochester

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.