Recruiting

Carbon Ion Therapy vs. Proton Therapy

Sponsor:

Mayo Clinic

Code:

NCT05033288

Conditions

Bone Sarcoma

Chondrosarcoma

Chordoma

Ewing Sarcoma of Bone

Pelvic Rhabdomyosarcoma

Eligibility Criteria

Sex: All

Age: 15+

Healthy Volunteers: Not accepted

Interventions

Electronic Health Record Review

Quality-of-Life Assessment

Study Details

Brief summary:

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.

Conditions

Bone Sarcoma

Chondrosarcoma

Chordoma

Ewing Sarcoma of Bone

Pelvic Rhabdomyosarcoma

Study ID

NCT05033288

Start date

Jan 20, 2022

Status verified date

Mar, 2026

Completion date

Aug 30, 2031

Anticipated

Primary completion date

Aug 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 15+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

72 participants

Anticipated

Interventions and Outcome Measures

Arms

Observational (questionnaires, medical record review)

Patients complete quality of life questionnaires over 20 minutes at baseline (before any therapy), 2-4 and 5-9 months after completion of therapy, and then annually for up to 5 years. Patients' medical records are also reviewed.

Interventions

Electronic Health Record Review

Medical records are reviewed

Quality-of-Life Assessment

Complete quality of life questionnaires

Primary outcome measure

  • Average difference in change of functional quality of life (QOL) [ Time Frame: Baseline (pre-treatment) to 1 year after completion of treatment ]
  • Proportion of patients experiencing local control [ Time Frame: Up to 5 years after completion of treatment ]
  • Progression-free survival - local control [ Time Frame: Up to 5 years after completion of treatment ]
  • Progression-free survival - regional control [ Time Frame: Up to 5 years after completion of treatment ]
  • Progression-free survival - distant control [ Time Frame: Up to 5 years after completion of treatment ]
  • Overall survival - local control [ Time Frame: Up to 5 years after completion of treatment ]
  • Overall survival - regional control [ Time Frame: Up to 5 years after completion of treatment ]
  • Overall survival - distant control [ Time Frame: Up to 5 years after completion of treatment ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Locations

Mayo Clinic in Arizona

Recruiting

Scottsdale, Arizona, United States, 85259

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Jonathan B. Ashman, MD, PhD

Mayo Clinic in Florida

Recruiting

Jacksonville, Florida, United States, 32224-9980

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Bradford S. Hoppe, MD

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Meng Welliver, MD, PhD

More Information

Sponsor

Mayo Clinic

Last update posted

Mar 13, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-03-13.