Trials / Recruiting
RecruitingNCT05033288
Comparing Carbon Ion Therapy, Surgery, and Proton Therapy for Management of Pelvic Sarcomas Involving the Bone
Prospective Comparative Effectiveness Trial of Carbon Ion Therapy, Surgery, and Proton Therapy for the Management of Pelvic Sarcomas (Soft Tissue/Bone) Involving the Bone
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 72 (estimated)
- Sponsor
- Mayo Clinic · Academic / Other
- Sex
- All
- Age
- 15 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Electronic Health Record Review | Medical records are reviewed |
| OTHER | Quality-of-Life Assessment | Complete quality of life questionnaires |
Timeline
- Start date
- 2022-01-20
- Primary completion
- 2027-08-30
- Completion
- 2031-08-30
- First posted
- 2021-09-02
- Last updated
- 2026-03-13
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05033288. Inclusion in this directory is not an endorsement.