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

NCT ID: NCT05033288

Last Updated: 2025-10-07

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 72 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-20
• Study Completion Date: 2028-08-30

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.

Detailed Description

PRIMARY OBJECTIVES:

I. Demonstrate whether carbon ion therapy provides improved patient reported health related quality of life (PRO-HRQOL) outcomes and less significant toxicities compared with surgery.

II. Demonstrate whether carbon ion therapy provides improved local control versus proton therapy.

OUTLINE:

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.

Conditions

Bone Sarcoma; Chondrosarcoma; Chordoma; Ewing Sarcoma of Bone; Pelvic Rhabdomyosarcoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Electronic Health Record Review

Intervention Type: OTHER

Medical records are reviewed

Quality-of-Life Assessment

Intervention Type: OTHER

Complete quality of life questionnaires

Interventions

Electronic Health Record Review

Medical records are reviewed

Intervention Type: OTHER

Quality-of-Life Assessment

Complete quality of life questionnaires

Intervention Type: OTHER

Other Intervention Names

Quality of Life Assessment

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

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bradford S. Hoppe, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Site Status: RECRUITING

Mayo Clinic in Florida

Jacksonville, Florida, United States

Site Status: RECRUITING

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Clinical Trials Referral Office

Role: CONTACT

mayocliniccancerstudies@mayo.edu

855-776-0015

Facility Contacts

Clinical Trials Referral Office

Role: primary

mayocliniccancerstudies@mayo.edu

855-776-0015

Clinical Trials Referral Office

Role: primary

mayocliniccancerstudies@mayo.edu

855-776-0015

Clinical Trials Referral Office

Role: primary

mayocliniccancerstudies@mayo.edu

855-776-0015

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

NCI-2021-08847

Identifier Type: REGISTRY

Identifier Source: secondary_id

MC210709

Identifier Type: OTHER

Identifier Source: secondary_id

21-004080

Identifier Type: OTHER

Identifier Source: secondary_id

ROF2181

Identifier Type: OTHER

Identifier Source: secondary_id

MC210709

Identifier Type: -

Identifier Source: org_study_id