Central-boost Ablative Radiation Therapy for Large Tumors or Tumors Adjacent to Organs at Risk
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- One-year local control will be determined.
研究概览
简要总结
In the case of large tumors or tumors closely adjacent to organs at risk, ablative doses offered by stereotactic body radiation therapy (SBRT) could not be delivered. Therefore, a technique that could provide high radiation doses to tumors without increasing of risks of severe adverse effects is required.
详细描述
Regarding the advanced stage tumor, especially tumors with large volumes or closely adjacent to organs at risk, patients are not candidates for surgical resection. Therefore, raduitherapy may be the optimal local therapy to ameliorate symptoms and be combined with systemic therapy, including chemotherapy, targeted therapy or immunotherapy. However, for those tumors, ablative doses could not be given due to large volumes and abutting to organs at risk.
In order to solve the problem, spatially fractionated radiation therapy (SFRT) is used. In details, it was performed based on grid or lattice, which creates several cylindrical high-radiation-dose areas in tumors. Nevertheless, the ablative dose areas are limited albeit with SFRT, which may not greatly improve tumor local. Hence, we create an inner and complete inner gross tumor volume that would be delivered ablative radiation doses, which is named as central-boost ablative radiation therapy (CBART). We aim to investigate the efficacy and safety of CBART in large tumors or tumors adjacent to organs at risk.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-75 years.
- •Pathologically confirmed lung, liver, pancreas or retroperitoneal malignant tumor.
- •Oligometastasis in the case of metastatic tumor
- •the shortest diameter ≥2cm or the distance from the tumor to the organs at risk less than 5mm
- •ECOG of 0 to 1 point
- •No abnormality in blood routine test, liver and kidney function test and coagulation test (White blood cell count ≥4.0×10^9/L, neutrophil count ≥2.0×10^9, hemoglobin level ≥100g/L, platelet count ≥100×10^9/L, ALT and AST level < 2.5 times the upper limit of normal, total bilirubin and creatinine level within the normal, international normalized ratio <2)
排除标准
- •History of radiotherapy for the lesion
- •History of tumor within 5 years
- •ECOG ≥2 points
- •Significant abnormality in blood routine test, liver and kidney function test and coagulation test
- •Active inflammatory bowel disease in the case of pancreas or retroperitoneal tumor
- •Gastrointestinal bleeding or perforation within 6 months in the case of pancreas or retroperitoneal tumor
- •Infections required antibiotics
- •Heart or respiratory insufficiency
- •Pregnant or breastfeeding women
研究组 & 干预措施
stereotactic body radiation therapy
Central-boost ablative doses delivered by SBRT.
干预措施: Central-boost ablative dose delivered by stereotactic body radiation therapy (Radiation)
结局指标
主要结局
One-year local control will be determined.
时间窗: 1 year
The proportion of patients without tumor local progression at one year. The progression is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST; version 1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
次要结局
- Overall survival will be determined.(2 years)
- Treatment related adverse events(2 years)
- Progression free survival will be determined.(2 years)