Prospective Comparative Effectiveness Trial of Carbon Ion Therapy, Surgery, and Proton Therapy for the Management of Pelvic Sarcomas (Soft Tissue/Bone) Involving the Bone
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.
Arms & interventions
- OtherElectronic Health Record Review
Medical records are reviewed
- OtherQuality-of-Life Assessment
Complete quality of life questionnaires
Outcome measures
Primary
Average difference in change of functional quality of life (QOL)
Will be compared between patients who received carbon ion radiation therapy (CIRT) and surgery utilizing a one-sided test for a two sample t-test for independent means. The Patient Reported Outcomes Measurement Information System (PROMIS)-29 functional score will be calculated and median, mean, and 95% confidence interval will be computed for each arm, with one-sided two-sample t-tests conducted between the surgery +/- radiation therapy (RT) and CIRT arm.
Time frame: Baseline (pre-treatment) to 1 year after completion of treatment
Proportion of patients experiencing local control
Will be calculated along with 95% confidence intervals with a one-sided test for non-inferiority to be conducted between the PT and CIRT arms.
Time frame: Up to 5 years after completion of treatment
Progression-free survival - local control
The Kaplan-Meier method with likelihood ratio tests will be used to calculate clinical outcomes including local control as well as progression-free survival for each arm and stratified by arm.
Time frame: Up to 5 years after completion of treatment
Progression-free survival - regional control
The Kaplan-Meier method with likelihood ratio tests will be used to calculate clinical outcomes including regional control as well as progression-free survival for each arm and stratified by arm.
Time frame: Up to 5 years after completion of treatment
Progression-free survival - distant control
The Kaplan-Meier method with likelihood ratio tests will be used to calculate clinical outcomes including distant control as well as progression-free survival for each arm and stratified by arm.
Time frame: Up to 5 years after completion of treatment
Overall survival - local control
The Kaplan-Meier method with likelihood ratio tests will be used to calculate clinical outcomes including local control as well as overall survival for each arm and stratified by arm.
Time frame: Up to 5 years after completion of treatment
Overall survival - regional control
The Kaplan-Meier method with likelihood ratio tests will be used to calculate clinical outcomes including regional control as well as overall survival for each arm and stratified by arm.
Time frame: Up to 5 years after completion of treatment
Overall survival - distant control
The Kaplan-Meier method with likelihood ratio tests will be used to calculate clinical outcomes including distant control as well as overall survival for each arm and stratified by arm.
Time frame: Up to 5 years after completion of treatment
Secondary
Secondary and exploratory analyses on toxicity data
Time frame: Up to 5 years after completion of treatment
Secondary and exploratory analyses on dose volume histogram (DVH) data
Time frame: Up to 5 years after completion of treatment
Dose volume histogram
Time frame: Up to 5 years after completion of treatment
Eligibility criteria
Study locations (3)
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
Mayo Clinic in Rochester
Rochester, Minnesota, 55905