Prospective Comparative Effectiveness Trial of Carbon Ion Therapy, Surgery, and Proton Therapy for the Management of Pelvic Sarcomas (Soft Tissue/Bone) Involving the Bone
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.
Eligibility
- Age range
- 15+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- OtherElectronic Health Record Review
Medical records are reviewed
- OtherQuality-of-Life Assessment
Complete quality of life questionnaires
Locations (3)
- Mayo Clinic in ArizonaScottsdale, Arizona
- Mayo Clinic in FloridaJacksonville, Florida
- Mayo Clinic in RochesterRochester, Minnesota