EUS-Guided Cryothermal Ablation in Patients With Stage III (Locally Advanced and Borderline Resectable) Pancreatic Adenocarcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Progression free survival
研究概览
简要总结
In patients with locally advanced tumour, neoadjuvant treatment has been proposed in various modalities as a way to decrease size and downstage the tumour leading to a re-sectable disease. The HybridTherm probe (HTP), (ERBE Elektromedizin GmbH, Tübingen, Germany) combines bipolar RF-ablation with cryogenic induced cooling. A bipolar radiofrequency system creates ablation with less collateral thermal damage than standard monopolar systems but with the trade-off to lose overall efficiency.
详细描述
About 40% of patients with pancreatic cancer have no metastasis at the moment of diagnosis, but in 20% of patients surgery is not feasible due to vascular invasion or poor general conditions. These patients with stage III pancreatic cancer (locally advanced or borderline resectable) may benefit from neoadjuvant chemotherapy or chemoradiotherapy. The HybridTherm probe is a new, minimally invasive device that can be safely applied under EUS guidance to locally ablate the pancreatic tissue adding a local efficacy to the systemic activity offered by chemotherapy and could give these patients a bigger chance of survival. The present study is an interventional randomized controlled phase II/III trial (device), that assigns patients into two groups: patients receiving standard chemotherapy alone and those receiving chemotherapy plus EUS-guided HybridTherm ablation. The randomization is performed at the time of EUS diagnosis and staging.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •pathological diagnosis
- •patients with borderline resectable/locally advanced pancreatic adenocarcinoma;
- •patients no previously treated with neoadjuvant treatments, irrespective of the regimen
- •age >18 years; ≤ 80
- •genders eligible for study: both
- •patients who can express their consent
- •Karnofsky Performance status >70;
- •Life expectancy >6 months.
- •PLT>100000/mcl; INR<1.
- •adequate renal function with a creatinine threshold
- •adequate bone marrow function (WBC ≥3500)
排除标准
- •pregnancy
- •acute pancreatitis
- •patients having distant metastasis
结局指标
主要结局
Progression free survival
时间窗: 6-months after therapy onset
To demonstrate the efficacy of the HybridTherm probe in the control of the tumour progression in terms of progression-free survival, measured at 6-month after ther-apy onset (PFS-6). PFS-6 takes in consideration the tumor growth in relation to the volume/size evaluated as a difference between the previous and the current examination. In practice, it is the time interval between the enrolment of the patient and the first radiological evidence of tumor progression. For patients who were resected (R0 and R1) the PFS is the time until the first radio-logical evidence of tumor recurrence, regardless size. For not resected patients the PFS is the time until the first radiological evidence of a growth of the lesion \> 20% in comparison to the previous exam.
次要结局
- Evaluation of cell disruption / necrosis of the treated area(At 2 and 4 months after the treatment)
- R0 Resection Rate:(After surgical resection)
- Rate of resectability(After 4 months pf treatment)
- Response to treatment(At 2 and 4 months after the treatment)
研究者
Paolo Giorgio Arcidiacono, MD
Head of Pancreatico-Biliary and Endosonography Division
IRCCS San Raffaele