Clinical Efficacy of Stereotactic Radiotherapy and Microwave Ablation for Liver Metastases From Colorectal Cancer: a Prospective Multicenter Cohort Study
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 6
- 主要终点
- PFS
研究概览
简要总结
Data of 100 colorectal cancer patients with liver metastases who received stereotactic radiotherapy of Cyberknife or microwave ablation in the multicenter of the research group from June 2019 to May 2021 were collected, as well as follow-up data.To evaluate the clinical efficacy of stereotactic radiotherapy and microwave ablation in liver metastases.In addition, the local control rate and side effects of stereotactic radiotherapy and microwave ablation in the treatment of liver metastases were explored, and the efficacy and safety of different doses of stereotactic radiotherapy were determined.
详细描述
In the study，data of 100 colorectal cancer patients with liver metastases who received Cyberknife stereotactic radiotherapy or microwave ablation in the multi-center of the research group from June 2019 to May 2021 were collected, as well as follow-up data.
- Radiation: Stereotactic Radiotherapy 1.1 Equipment: Accuray VSI Cyberknife stereotactic radiotherapy platform, simulated positioning CT machine, MR, positron emission computed tomography PET-CT, vacuum pad.
1.2 Radiotherapy localization: CT, MRI and PETCT were used to simulate localization.
1.3 Relevant Definitions of Tumor Targets CT, MRI, PET-CT fusion, combined with MRI location and PET-CT location image for sketching.
To delineate target areas and organs at risk. GTV: Combining localization and fusion images to delineate the tumors seen PTV = GTV + 0-10mm Dangerous organs: The stomach, duodenum, jejunum, ileum, colon, spinal cord and esophagus were delineated on the base sequence of CT plain scan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The age was 18 to 80 years old.
- •It was confirmed by pathology that the liver metastasis of colorectal cancer was less than or equal to 3 lesions, each lesion was less than 3 cm, and there was no invasion of vascular tumor thrombus and adjacent organs according to the discussion of MDT.
- •The preoperative imaging evaluation of iatrogenic or / and personal factors can realize microwave ablation or radiosurgery SBRT to require.
- •The primary lesion has been treated radical and has no evidence of recurrence, and there is no metastasis outside the liver.
- •The physical status score of ECOG : 0 ≥ 1 or more than 60 KPS.
- •Predicted survival time was more than 3 months.
- •The main organ function can tolerate stereotactic radiotherapy / microwave ablation, liver function child-pugh A or B, no severe hypertension, diabetes and heart disease. That is, within 14 days of random examination, the relevant test indexes meet the following requirements:
- •blood routine examination: i. Hemoglobin was more than 90 g /L (no blood transfusion); ii. Neutrophil count was more than 1.5x109/L; iii platelet count was more than 100x109/ L;
- •biochemical examination: i. total cholerythrin-1.5-ultraln (upper limit of normal); ii. Blood-valley-pyruvic transaminase (ALT) or blood-glutamic-aspartate aminotransferase (AST), 2.5-hulled; iii. The clearance of endophytic muscle was 60 ml/ min (ckroft-gault formula);
- •cardiac Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) was more than 50%;
- •blood glucose control was less than 7.2 mmol/ L, non-fasting blood glucose was less than 10 mmol/L, and glycosylated hemoglobin was less than 7%.
- •Sign informed consent form.
- •Good compliance, family agreed to cooperate with follow-up.
排除标准
- •Patients who are being treated with drugs and whose liver metastases are stable or relieved, and who have participated in clinical trials of other drugs within four weeks;
- •There was a history of bleeding, and any serious bleeding events of 3 degrees or more in ctcae 5.0 occurred within 4 weeks before screening.
- •Patients with known central nervous system metastasis or history of central nervous system metastasis before screening. For patients with suspected central nervous system metastasis, CT or MRI examination must be performed within 14 days before randomization to exclude central nervous system metastasis.
- •Patients with high blood pressure and single step-down medications were not able to obtain good control (systolic blood pressure was more than 140 mmHg, diastolic blood pressure was more than 90 mmHg); patients with a history of unstable angina; a new diagnosis within 3 months before screening was an event of myocardial infarction within 6 months before or after screening; Arrhythmias (including QTCF: male,450 ms, female, 470ms) require long-term use of anti-arrhythmic drugs and the New York Heart Association rating of grade ii cardiac insufficiency;
- •Long-term unhealed wounds or incomplete fractures,
- •Imaging showed that the tumor had invaded the perivascular area of important vessels or was judged by researchers that the tumor was highly likely to invade important blood vessels during treatment, resulting in fatal massive bleeding.
- •Patients with abnormal coagulation function and bleeding tendency (14 days before randomization must be satisfied:INR is within the normal range without anticoagulant); Patients treated with anticoagulant or vitamin k antagonists such as warfarin, heparin or its analogues; Low dose warfarin (1mg oral, once a day) or low dose aspirin (not exceeding 100 mg); per day) is allowed for prophylactic purposes on the premise that the international standardized ratio of prothrombin time (INR) was less than 1.5;
- •Hyperarteriovenous thrombosis occurred within 6 months before screening, such as cerebrovascular accidents (including temporary ischemic seizures), Deep venous thrombosis (except where venous thrombosis caused by intravenous catheterization after pre-chemotherapy has been cured by researchers) and pulmonary embolism, etc.
- •There was abnormal thyroid function in the past, and even in the case of drug treatment, thyroid function could not be maintained within the normal range;
- •Having a history of psychotropic substance abuse and unable to give up or have mental disorders.
- •Radiotherapy for abdominal tumors has been carried out in the past.
- •Have a history of immunodeficiency, or suffer from other acquired, congenital immunodeficiency diseases, or have a history of organ transplantation.
- •According to the researchers' judgment, there are serious diseases that endanger the safety of patients or affect the completion of the study.
研究组 & 干预措施
Stereotactic radiotherapy
In this study, the liver metastases were treated with Cyberknife stereotactic radiotherapy.Using multimodal image fusion to outline the target area.According to the volume, location, organ function and other factors, the dosage of radiotherapy was determined. The range of BED value of radiotherapy was 90-120 when the distance between the tumor and gastrointestinal tract was more than 5 mm (alpha/beta=10) and 70-90 when the distance between the tumor and gastrointestinal tract was less than 5 mm (alpha/beta=10).
干预措施: stereotactic radiotherapy (Radiation)
Microwave ablation therapy
In this study, 3D printing template was used to assist microwave ablation.For those whose lesions are directly smaller than 5.0cm, the ablation time is about 10 min and 15 min, and the ablation time is more than 15min in patients larger than 5.0cm.
干预措施: microwave alabation (Other)
结局指标
主要结局
PFS
时间窗: 3 years after the treatment
The time interval of disease progression since the date of diagnosis
Objective response rate
时间窗: 1 years after the treatment
The proportion of patients whose tumors have shrunk to a certain extent and maintained for a certain period of time, including CR + PR cases
Disease control rate
时间窗: 3 years after the treatment
After treatment, the number of cases with remission and stable lesions accounted for the percentage of the total number of assessable cases
Local control rate
时间窗: 3 years after the treatment
Local control refers to the fact that the tumor is not enlarged on imaging, but if the tumor is not enlarged, the patients with aggravated symptoms after treatment are not included in the local control range.
次要结局
- Overall survival(3 years after the treatment)
- Quality of life score of tumor patients(0-60)(3 years after the treatment)
- Side effects(1 years after the treatment)