Phase I/II Trial of Stereotactic Body Radiotherapy for the Treatment of Solitary Bone Plasmacytoma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Progression-free survival for multiple myeloma
研究概览
简要总结
This project aims to propose a new approach in the treatment of solitary plasmacytoma: hypofractionated irradiation alone with stereotactic technique that may contribute to the successful treatment of this disease.
This work aims to apply this new technique with the primary objective of reducing the progression-free survival for multiple myeloma of patients treated for solitary plasmacytoma, as well as quantify overall survival, local control, toxicities and quality of life in a phase I trial / II.
详细描述
Solitary plasmacytoma is a rare disease whose treatment has not evolved much in the last decades. The role of radiotherapy in the curative treatment of this entity was defined in a major publication in the 1980s and has since been proven to be the best practice in several other comparative trials, mostly retrospective. The radiotherapy dose of curative intent has also been described over the same period and remains unchanged to this day. Thus, local control, disease cure rate, and rate and progression time for multiple myeloma have been unaffected for almost 30 years.
Radiobiology of plasmacytoma cells is also not widely studied. The alpha / beta ratio, which defines the pattern of response of this disease to radiotherapy fractions and its response time, is also not well described. However, it is believed to be smaller in comparison to other hematological malignancies due to reports of cases of intrinsic radioresistance and late recurrence and reports of success with hypofractionated dose in isolated cases where stereotactic techniques were used such as base of skull and spine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Biopsy proven plasmacytic for the index lesion;
- •Age between 18 and 85 years;
- •ECOG scale performance of 0 to 2
排除标准
- •Refuse to sign or inability to understand the term of free and informed commitment (TCLE);
- •Technical limitations for treatment with SBRT among which is cited, but not limited to, weight greater than 115 Kg, inability to abduct limb to be treated in appendicular bone plasmocytomas, intolerable pain to remain in treatment position;
- •Criteria for multiple myeloma at diagnosis: more than 10% of plasma cells in bone marrow biopsy, hypercalcemia greater than 11.5 mg/dL, serum creatinine greater than 2mg/dL, creatinine clearance less than 40mL/min , Hemoglobin less than 10g/dL.
- •Previous cancer diagnosis and treatments;
- •Previous bone events such as fractures and osteomyelitis in the bone in which the index lesion is found;
- •Prior autoimmune diseases, even if controlled;
- •Extra-medullary plasmacytoma requiring elective treatment of lymph node drainage;
- •Current pregnancy
结局指标
主要结局
Progression-free survival for multiple myeloma
时间窗: 5 years
Progression-free survival for multiple myeloma at 5 years evaluation in patients undergoing SBRT for solitary plasmacytoma compared to a retrospective cohort of patients
次要结局
- Survival free of bone events(5 Years)
- Local control rate(5 years)
- Overall survival(5 years)
- Toxicities(5 Years)
- Quality of Life(5 years)
研究者
Geovanne Pedro Mauro
MD
Instituto do Cancer do Estado de São Paulo