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
Location: See all (3) locations...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 15
Healthy Volunteers: f
View:

• 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 with assistance

• Ability to provide written informed consent

• Chemotherapy per institutional guidelines is allowed

Locations
United States
Arizona
Mayo Clinic in Arizona
RECRUITING
Scottsdale
Florida
Mayo Clinic in Florida
RECRUITING
Jacksonville
Minnesota
Mayo Clinic in Rochester
RECRUITING
Rochester
Contact Information
Primary
Clinical Trials Referral Office
mayocliniccancerstudies@mayo.edu
855-776-0015
Time Frame
Start Date: 2022-01-20
Estimated Completion Date: 2028-08-30
Participants
Target number of participants: 72
Treatments
Observational (questionnaires, medical record review)
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.
Sponsors
Leads: Mayo Clinic

This content was sourced from clinicaltrials.gov

Similar Clinical Trials