Actively Recruiting
Prospective Comparative Effectiveness Trial of Carbon Ion Therapy, Surgery, and Proton Therapy for Management of Pelvic Sarcomas Involving the Bone
Led by Mayo Clinic · Updated on 2026-03-13
72
Participants Needed
3
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating three treatment approaches—carbon ion therapy, surgery (with or without photon/proton therapy), and proton therapy alone—for patients with pelvic bone sarcomas. The study aims to compare how these treatments affect disease control and quality of life, focusing on whether carbon ion therapy offers better patient-reported health outcomes and fewer side effects compared to surgery, as well as improved local control compared to proton therapy. Participants receive one of the three treatments and complete quality of life questionnaires at several points: before any therapy, between 2 to 4 months, and again at 5 to 9 months after treatment completion, followed by annual assessments for up to five years. Researchers also review patients' medical records to gather detailed clinical data. This observational study involves collecting patient-reported outcomes and medical information without assigning treatments. Throughout the study, patients are asked to complete questionnaires taking about 20 minutes to assess their health-related quality of life. These assessments occur at baseline and various follow-up points up to five years after treatment. Researchers monitor disease progression, local control of the sarcoma, survival outcomes, and treatment-related toxicities. The study's follow-up and data collection span several years to better understand long-term effects and outcomes of the different treatment approaches.
CONDITIONS
Brief Title
Comparing Carbon Ion Therapy, Surgery, and Proton Therapy for Management of Pelvic Sarcomas Involving the Bone
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females 15 years of age or older
- Newly diagnosed with histologic confirmation of pelvic chordoma, chondrosarcoma, osteosarcoma, Ewing sarcoma with bone involvement, rhabdomyosarcoma with bone involvement, or non-rhabdomyosarcoma soft tissue sarcoma with bone involvement
- No evidence of distant sarcoma metastases by clinical examination and imaging
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Patients capable of childbearing must agree to use adequate contraception
- Ability to complete quality of life questionnaires by themselves or with assistance
- Ability to provide written informed consent
- Chemotherapy per institutional guidelines is allowed
You will not qualify if you...
- Patients receiving palliative treatment
- Recurrent disease
- Males and females younger than 15 years of age
- Previous radiation therapy to the site of the sarcoma or surrounding area that would overlap with current treatment volume
- Presence of distant sarcoma metastases
- Benign pelvic bone histologies
- Pregnant or nursing women
- Men or women of childbearing potential unwilling to use adequate contraception
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Baseline before therapy
Participants complete quality of life questionnaires before any therapy and their medical records are reviewed.
1 baseline visit (in-person or remote)
Duration - Up to 5 years after completion of therapy
Participants complete quality of life questionnaires at 2-4 months, 5-9 months after completion of therapy, and then annually for up to 5 years. Medical records are also reviewed during this time.
1 to 2 visits at 2-4 and 5-9 months, then annual visits for up to 5 years
Trial Site Locations
Total: 3 locations
1
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
Actively Recruiting
2
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980
Actively Recruiting
3
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
C
Clinical Trials Referral Office
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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