3D-printing Template-assisted CT-guided I125 Seed Implantation and Stereotactic Radiotherapy for Locally Advanced Pancreatic Cancer:A Prospective Multicenter Cohort Study
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Overall survival (OS)
研究概览
简要总结
Data of 100 patients with locally advanced pancreatic cancer who received stereotactic radiotherapy or ct-guided radioactive 125I seed implantation in the multicenter of the research group from July 2019 to June 2021 were collected, as well as follow-up data.To evaluate the clinical efficacy of stereotactic radiotherapy and ct-guided 125I seed therapy with 3D printing template in pancreatic cancer;In addition, the local control rate and side effects of ct-guided radioactive 125I particles in the treatment of pancreatic cancer lesions were explored, and the efficacy and safety of different doses of stereotactic radiotherapy were determined.
详细描述
- 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.
The target area should be approved by at least one physician in charge or by a physician in charge.
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
- •Age: 18-80 years old;
- •Pathologically diagnosed pancreatic cancer patients;Follow-up treatment is in accordance with the NCCN2019 guidelines for standard treatment.
- •Clinical MDT discussion, for the unresectable locally advanced pancreatic cancer, AJCC version 8 pancreatic cancer stage T4N0M0
- •Arterial invasion:
- •The pancreatic head and neck tumor invasion of pancreas superior mesenteric artery exceed 180 °;More than 180 ° celiac tumor invasion;The tumor invaded the first jejunal branch of the superior mesenteric artery.The pancreatic body tail superior mesenteric artery or celiac tumor invasion more than 180 °;The tumor invaded the abdominal trunk and abdominal aorta.
- •Venous invasion:
- •Tumor invasion or embolization (tumor thrombus or thrombus) of the head and neck of the pancreas leads to unresectable superior mesenteric vein or portal vein reconstruction;The tumor invaded the proximal end jejunal drainage branch of most superior mesenteric veins.The invasion or embolization of a tumor in the tail of the pancreas (thrombus or thrombus) leads to the unresectable reconstruction of the superior mesenteric vein or portal vein.
- •ECOG physical condition score: 0-1, Karnofsky score 60, able to withstand puncture;
- •Expected survival 3 months;
- •Good function of main organs, no severe hypertension, diabetes and heart disease.
- •Signed informed consent;
- •Has a good compliance, families agree to accept the survival follow-up.
排除标准
- •Non-locally advanced pancreatic cancer.
- •Participated in other drug clinical trials within four weeks;There was a history of bleeding, and any bleeding event with severe grade of CTCAE5.0 or above occurred within 4 weeks before screening;
- •Screening of patients with known central nervous system metastasis or a history of central nervous system metastasis.
- •Patients with hypertension who cannot obtain good control by single antihypertensive drug treatment (systolic blood pressure >140mmHg, diastolic blood pressure >90mmHg);Having a history of unstable angina pectoris;Patients newly diagnosed with angina within 3 months before screening or myocardial infarction within 6 months before screening;Arrhythmia (including QTcF: 450ms in male and 470ms in female) requires long-term use of anti-arrhythmia drugs and New York heart association grade II cardiac dysfunction;
- •Long-term unhealed wounds or incomplete fracture healing;
- •Imaging showed that the tumor had invaded important blood vessels or the researchers judged that the patient's tumor had a very high possibility to invade important blood vessels during the treatment and cause fatal bleeding;
- •Coagulation function abnormalities, have bleeding tendency;Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or their analogues;The use of low-dose warfarin (1mg oral, once daily) or low-dose aspirin (no more than 100mg daily) for preventive purposes is permitted on the premise that the international standardized ratio of prothrombin time (INR) is 1.5;
- •Screening for the occurrence of hyperactive/venous thrombosis events in the first 6 months, such as cerebrovascular accidents (including temporary ischemic attack), deep vein thrombosis (except for venous thrombosis caused by intravenous catheterization in the early stage of chemotherapy, which was determined by the researchers to have recovered) and pulmonary embolism, etc.
- •Thyroid function was abnormal in the past and could not be kept within the normal range even in the case of drug treatment.
- •Attending has a history of psychotropic drug abuse, and can't attend or has mental disorder;
- •Always half a year after abdominal tumor lesion radiation;
- •Immunodeficiency disease, or has other acquired, congenital immunodeficiency disease, or has a history of organ transplantation;
- •Judgment according to the researchers, there is serious to endanger the safety of patients or patients completed the research associated with disease.
研究组 & 干预措施
I125 Seed Implantation
3D-printing Template-assisted CT-guided I125 Seed Implantation Prescription dose: gtv140-160gy ctv100-140gy Particle activity: 0.4-0.5mCi
干预措施: Stereotactic Radiotherapy (Radiation)
Stereotactic Radiotherapy
According to the tumor volume, location, organ function and other factors, the dosage of stereotactic directional radiotherapy was determined. The range of BED value of radiotherapy was 80-100 for tumors above 5 mm from gastrointestinal tract and 60-80 for tumors below 5 mm from gastrointestinal tract.
干预措施: 3D-printing Template-assisted CT-guided I125 Seed Implantation (Radiation)
结局指标
主要结局
Overall survival (OS)
时间窗: 3 years after the treatment
The time from enrollment to death from any cause
Progression-free survival (PFS)
时间窗: 3 years after the treatment
the time interval of disease progression since the date of diagnosis
次要结局
- Pain score(1 years after the treatment)
- Qol: Quality of Life Score of Tumor Patients(3 years after the treatment)
- Local control rate，LCR(3 years after the treatment)
- Adverse reactions(1 years after the treatment)