Comparing Carbon Ion Therapy, Surgery, and Proton Therapy for the Management of Pelvic Sarcomas Involving the Bone, the PROSPER Study
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- STATUS
- Recruiting
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- End date
- Aug 30, 2028
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- participants needed
- 180
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- sponsor
- Mayo Clinic
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.
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.
Details
| Condition | Bone Sarcoma, Chondrosarcoma, Chordoma, Ewing Sarcoma of Bone, Pelvic Rhabdomyosarcoma |
|---|---|
| Treatment | quality-of-life assessment, Electronic Health Record Review |
| Clinical Study Identifier | NCT05033288 |
| Sponsor | Mayo Clinic |
| Last Modified on | 18 June 2022 |
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