Study of Effectiveness of Stereotactic Body RadioTherapy and Stereotactic RadioSurgery in Solid Primary Inoperable and Oligometastatic Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Relapse Rate (local and/or distant)
研究概览
简要总结
The purpose of this study is to development of more effective treatment tactics of the stereotactic radiotherapy and radiosurgery alone and together with classic radiation therapy in primary inoperabel solid tumors and oligometastastatic cancer.
详细描述
Despite the fact that of many investigations in the world clinical researches, the SRT of primary-inoperabel and metastatic solid tumors combined with conventional and conformal radiation therapy methods the possibility of the sequences, the optimal fractions of the regimes and doses which determines normal tissues toxic manifestations, implementation of prevention, have not been solved yet.
The conducted research works to study quality of life for improving the social status of patients with primary-inoperable and metastatic solid tumors, is not fully resolved.
Thus, preparing of highly effective treatment tactics in primary-inoperable and metastatic solid tumors, is one of the most important problems of modern clinical oncology and this fact gives grounds to carry out the planned research work.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Histologically confirmed primary-inoperable solid tumors or oligometastatic cancer.
- •Acceptance of patient by surgeon as non-operabel or refusing of surgery.
- •No more than 4 metastatic foci in irradiated organ.
- •Karnofsky scale more than
- •Age ≥18 years.
- •Estimated duration of life >3 months.
- •Hemoglobin ≥ 8 g/dl.
- •Absolute neutrophil count at least 1,500/mm^
- •Platelet count at least 70,000/mm^
- •Bilirubin no greater than 1.5 times normal.
- •SGOT and SGPT no greater than 3 times normal.
- •Creatinine less than 1.5 mg/dL. PT-INR/APTT less than 1.
- •Last patients data no older than 1 month.
- •No prior radiotherapy of same location.
- •Prior chemottherapy more than 2 weeks ago.
排除标准
- •Progression of primary site of metastatic cancer.
- •Pregnancy or Breast-Feeding.
- •Decompensated concomitant diseases.
结局指标
主要结局
Relapse Rate (local and/or distant)
时间窗: 5 years
clinical-instrumental or laboratory signs of local and/or distant recurrences of previously diagnosed oncological diaseases
Number of Deaths Due to Any Cause
时间窗: 5 years
Deaths due to any complications or progression of previously diagnosed oncological diaseases
次要结局
- Incidence of acute toxicity(Up to 90 days after completion of radiation therapy)
- Incidence of late toxicity(Up to 2 years after completion of radiation therapy)
研究者
Azer Aliyev
Radiation Oncologist, PhD
The National Center of Oncology, Azerbaijan