Part A: Effect of Prophylactic Vertebroplasty Combined With Radiation Therapy for Spine Metastatic Cancer Patients With Indeterminate Lesion (SINS Criteria)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Vertebral compression fracture (VCF) rate
研究概览
简要总结
This clinical trial studies the side effects of stereotactic radiosurgery and how well it works with or without vertebroplasty, separation surgery, or immunotherapy in patients with cancer that is radiation resistant and has spread to the spine (spinal metastases). Spinal metastases are rapidly progressive, have poor prognosis, are extremely difficult to treat, and can effect patient quality of life and overall health. Immunotherapy is a type of standard of care therapy to boost or restore the ability of the immune system to fight cancer. Stereotactic radiosurgery is a type of external radiation therapy that uses special equipment to position the patient and precisely give a single large dose of radiation to a tumor. A vertebroplasty is a procedure used to repair a bone in the spine that has a break caused by cancer, osteoporosis, or trauma. The purpose of this trial is to test different combinations of immunotherapy, stereotactic radiosurgery, and surgery to improve overall survival and quality of life in patients with spinal metastases.
详细描述
PRIMARY OBJECTIVE:
I. To determine the overall efficacy and safety of stereotactic radiosurgery (SRS) with or without vertebroplasty or separation surgery in patients with radiation resistant histologies metastatic to the spine with or without concurrent immunotherapy with PD1 blockade.
SECONDARY OBJECTIVES:
I. To assess 6 month vertebral compression fracture (VCF) rate. II. To assess local control (LC) and distant disease control rates. III. To assess the progression free survival (PFS). IV. To assess the overall survival (OS). V. To assess potential vertebral compression fracture (VCF) risk in cancer patients with spinal metastases (SM).
VI. To assess changes in pain from baseline with patient reported measures, medication changes, and quality of life (QoL) measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years of age and older with indeterminate Spine Metastasis.
- •All patients with histology that requires stereotactic RT as a part of their treatment.
- •Eastern Cooperative Oncology Group (ECOG) performance status =< 2
- •Disease visualized by CT or MRI
- •Prior radiation therapy will be allowed at the discretion of the Radiation Oncologist based on current standard operating procedures.
- •Tumor tissue from the core biopsy or resected site of disease will be collected, if available for biomarker analyses.
- •Four or less consecutive spinal segments involved by tumor. Or four or less separate spinal tumor targets with a minimum of one vertebral body separation
- •Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life questionnaire in either English or Spanish. The baseline assessment must be completed within required timelines. Inability (illiteracy in English or Spanish, loss of sight, or other equivalent reason) to complete the questionnaires will not make the patient ineligible for the study. However, ability but unwillingness to complete the questionnaires will make the patient ineligible
排除标准
- •Patients < 18 years of age
- •Inability to get a standard MRI or CT myelogram for radiation treatment target delineation
- •Patients with prior radiation to the spinal segment to be treated may be included if the radiation dose can be delivered safely, per the treating radiation oncologist.
- •Patients with symptomatic spinal cord compression requiring emergent surgery
- •Pregnant or lactating women
- •Systemic therapy or immunosuppressive medications, excluding immunotherapy, within 3-14 days of radiation treatment, at the discretion of the treating radiation oncologist .
- •Patients with stable or unstable lesions based on SINS criteria
研究组 & 干预措施
Arm II (no vertebroplasty)
Patients receive standard of care immunotherapy IV every 2 weeks for up to 6 months and undergo SRS over 1-3 fractions depending upon the number of affected vertebral bodies in the absence of disease progression or unacceptable toxicity.
干预措施: Immunotherapy (Other)
Arm I (vertebroplasty)
Patients undergo vertebroplasty and, 2-4 weeks later, undergo SRS over 1-3 fractions depending upon the number of affected vertebral bodies. Patients also receive standard of care immunotherapy IV every 2 weeks for up to 6 months in the absence of disease progression or unacceptable toxicity.
干预措施: Stereotactic Radiosurgery (Radiation)
Arm I (vertebroplasty)
Patients undergo vertebroplasty and, 2-4 weeks later, undergo SRS over 1-3 fractions depending upon the number of affected vertebral bodies. Patients also receive standard of care immunotherapy IV every 2 weeks for up to 6 months in the absence of disease progression or unacceptable toxicity.
干预措施: Vertebroplasty (Procedure)
Arm I (vertebroplasty)
Patients undergo vertebroplasty and, 2-4 weeks later, undergo SRS over 1-3 fractions depending upon the number of affected vertebral bodies. Patients also receive standard of care immunotherapy IV every 2 weeks for up to 6 months in the absence of disease progression or unacceptable toxicity.
干预措施: Immunotherapy (Other)
Arm II (no vertebroplasty)
Patients receive standard of care immunotherapy IV every 2 weeks for up to 6 months and undergo SRS over 1-3 fractions depending upon the number of affected vertebral bodies in the absence of disease progression or unacceptable toxicity.
干预措施: Stereotactic Radiosurgery (Radiation)
结局指标
主要结局
Vertebral compression fracture (VCF) rate
时间窗: At 6 months
Will be summarized for all patients overall and by each cohort. The confidence interval of the overall VCF rate within 6 months will be calculated using binomial exact test for each cohort.
Local control
时间窗: At 6 months
Will be summarized for all patients overall and by each cohort. Will be summarized using Kaplan-Meier survival analysis.
次要结局
- Objective response rate(Up to 1 year)
- Overall survival(Up to 1 year)
- Abscopal effects(Up to 1 year)
- Progression-free survival(Up to 1 year)
- Change in health-related quality of life(Baseline up to 1 year)
研究者
Dukagjin Blakaj
Principal Investigator
Ohio State University Comprehensive Cancer Center