Prospective Comparative Effectiveness Trial of Carbon Ion Therapy, Surgery, and Proton Therapy for the Management of Pelvic Sarcomas (Soft Tissue/Bone) Involving the Bone
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 72
- 试验地点
- 6
- 主要终点
- Progression-free survival - local control
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Electronic Health Record Review (Other)
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.
干预措施: Quality-of-Life Assessment (Other)
结局指标
主要结局
Progression-free survival - local control
时间窗: Up to 5 years after completion of treatment
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.
Progression-free survival - regional control
时间窗: Up to 5 years after completion of treatment
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.
Progression-free survival - distant control
时间窗: Up to 5 years after completion of treatment
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.
Overall survival - local control
时间窗: Up to 5 years after completion of treatment
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.
Overall survival - regional control
时间窗: Up to 5 years after completion of treatment
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.
Overall survival - distant control
时间窗: Up to 5 years after completion of treatment
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.
Average difference in change of functional quality of life (QOL)
时间窗: Baseline (pre-treatment) to 1 year after completion of treatment
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.
Proportion of patients experiencing local control
时间窗: Up to 5 years after completion of treatment
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.
次要结局
- Secondary and exploratory analyses on toxicity data(Up to 5 years after completion of treatment)
- Secondary and exploratory analyses on dose volume histogram (DVH) data(Up to 5 years after completion of treatment)
- Dose volume histogram(Up to 5 years after completion of treatment)