Electrochemotherapy of Posterior Resection Surface for Lowering Disease Recurrence Rate in Pancreatic Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Evaluation of feasibility and safety
研究概览
简要总结
The aim of the study is to evaluate toxicity and effectiveness of electrochemotherapy (ECT) with bleomycin in pancreatic cancer in clinical study phase I and II. After surgical resection of pancreatic cancer, the posterior resection surface will be treated with ECT with the intention to lower disease recurrence rate.
The study will include 20 patients in phase I clinical study and additional 20 patients in phase II clinical study (or in the extension of the clinical study), which will fulfill inclusion criteria.
Treatment effectiveness will be evaluated by US or CT imaging, to detect early local recurrence of the disease. Long term effectiveness of the treatment will be evaluated by frequent and precise patient follow-up. During follow-up clinical examination, laboratory tests, tumor markers (Ca 19-9 and CEA) and US/CT imaging will be performed.
The secondary objectives of the trial are to quantify the impact of the treatment on the patient's quality of life, tolerance to the therapy and suitability for larger study to be conducted.
详细描述
The study will be conducted on patients with resectable pancreatic cancer. 20 patients will be included in phase I clinical study and additional 20 patients in phase II clinical study (or in the extension of the clinical study).
After surgical resection of pancreatic cancer, the posterior resection surface will be treated with purpose to lower disease recurrence rate. Plate electrodes will be used for ECT treatment, the electrodes will be placed between choledochal cut-end, truncus celiacus, remaining of the pancreas and aortal lymph nodes.
ECT will be performed within 8-28 min after intravenous in bolus administration of bleomycin (15 mg/m2). Triggering of electric pulses will be synchronized with ECG signals, through the ECG triggering device AccuSync to avoid delivery of pulses in vulnerable period of the heart.
All patients will be treated after the procedure has been thoroughly described to them and have signed informed consent.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with resectable pancreatic cancer.
- •Histologically confirmed and/or based on radiological imaging and laboratory tests confirmed pancreatic cancer by multidisciplinary team for pancreatic tumors.
- •Age more than
- •Life expectancy more than 3 months.
- •Performance status - Karnofsky ≥ 70 or WHO < or
- •Treatment free interval 2-5 weeks, depending on the drugs used.
- •Patient must be mentally capable of understanding the information given.
- •Patient must give informed consent.
- •Patient must be discussed at the multidisciplinary team for pancreatic tumors before entering the trial.
排除标准
- •Secondary primary tumor, except surgically treated noninvasive cancer of cervix, or surgically or irradiated basal cell carcinoma.
- •Proven visceral, bone or diffuse metastases.
- •Life-threatening infection and/or heart failure and/or liver failure and/or renal failure (creatinine more than 150 µmol/L) other severe systemic pathologies.
- •Significant reduction in respiratory function.
- •Age less than 18 years.
- •Cumulative dose of 250 mg/m2 bleomycin received.
- •Allergic reaction to bleomycin.
- •Patients with epilepsy.
- •Patients with arrhythmias.
- •Patients with heart failure or pacemaker.
- •Patient incapable of understanding the aim of the study or disagree with the entering into the clinical study.
结局指标
主要结局
Evaluation of feasibility and safety
时间窗: 7 days after operation
Every patient will be closely followed-up after operation with clinical examination and blood tests (hemogram, comprehensive metabolic panel, liver panel) according to the study protocol (day 1, 3, 7 after operation). In case of detected abnormalities additional imaging (US and/or CT) will take place. Findings will be noted and reported in line with Clavien-Dindo classification of surgical complications. The primary measure is to detect complications after surgery and to determine whether the complication is related to electrochemotherapy treatment or not.
次要结局
- Disease-free Survival(1, 3, 6, 12, 18 and 24 months after operation)
- Overall Survival(From the time of surgical treatment until 5 years after surgery)
研究者
Masa Bosnjak
Masa Bosnjak, PhD, researcher at Institute of Oncology Ljubljana (Collaborator)
University Medical Centre Ljubljana