An official website of the United States government
NIH Websites Are Changing Per Executive Order 14434, federal agencies are now using "Super Intelligence" (SI) in place of "Artificial Intelligence" (AI). You may see both terms across NIH content during this transition.
Comparing Carbon Ion Therapy, Surgery, and Proton Therapy for the Management of Pelvic Sarcomas involving the Bone, the PROSPER Study
Trial Status: active
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.
Inclusion Criteria
Males and females >= 15 years of age
Newly diagnosed, histologic confirmation of pelvic chordoma, chondrosarcoma, osteosarcoma, or non- rhabdomyosarcoma (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
Patients with Ewing sarcoma and RMS are eligible if the tumors involve bone and are staged as T2b,T3b, T4a or T4b per the American Joint Cancer Committee (AJCC) 8th Edition Bone Sarcoma staging
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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05033288.
Locations matching your search criteria
United States
Arizona
Scottsdale
Mayo Clinic in Arizona
Status: Active
Contact: Jonathan Ben Ashman
Phone: 480-342-2000
Florida
Jacksonville
Mayo Clinic in Florida
Status: Active
Contact: Bradford Scott Hoppe
Phone: 904-953-1000
Minnesota
Rochester
Mayo Clinic in Rochester
Status: Active
Contact: Meng Xu Welliver
Phone: 507-284-3261
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.
