Prospective, single-center, randomized, two-arm, open phase I / II study on feasibility, safety and efficacy of local treatment with high intensity focused ultrasound (HIFU) in combination with standard chemotherapy in patients with inoperable pancreatic cancer - HIFU-PC15

niversitätsklinikum Bonn0 个研究点目标入组 40 人开始时间: 2017年7月6日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•Age = 18 years
•informed written consent to participate in the study
•Patients who are able to follow the study instructions and attend required study visits (compliance)
•Patients with inoperable, histologically or cytologically proven pancreatic cancer with a minimum size of 2 cm: newly diagnosed, locally advanced pancreatic carcinoma, primary metastasized pancreatic carcinoma, or local recurrence after R0 or R1 resection of a pancreatic carcinoma
•ECOG = 2
•Life expectancy >3 months
•Patients with indication for palliative first-line chemotherapy (gemcitabine as monotherapy, gemcitabine in combination with nab paclitaxel, erlotinib or oxaliplatin, 5-FU or capecitabine as monotherapy or in combination with oxaliplatin and / or irinotecan)
•Patients with adequate organ function: absolute neutrophils = 1.5 x10^9 / L; Haemoglobin = 8 g / dL; Thrombocyte count = 75 x10^9 / L; AST / ALT = 5x of the standard value; ?-GT = 5x of the standard value; Creatinine in the normal range or creatinine clearance = 50 mL / min
•Adequate sonographic visibility of the tumor as well as safe acoustic pathway to the tumor
•Distance between the skin surface and the most distant focus in the tumor max. 11 cm
•Patients suitable for general anesthesia
•Women of childbearing age must use a reliable method of prevention during treatment; Negative pregnancy test (ß-HCG test in the urine)

•? Age <18 years
•? Patient does not agree to the study
•? Patient not able to understand the scope, significance and consequences of this clinical trial
•? Inability of the patient to follow the study course
•? Simultaneous participation in another clinical trial or participation in a clinical trial with the taking of an investigational medicinal product up to 30 days prior to participation in this clinical trial
•? Patients do not meet laboratory requirements
•? Pregnancy or lactation
•? The tumor is not sufficiently visible on ultrasound after surgery, e.g. due to postoperative scars, extensive adhesions
•? Explorative laparotomy less than 6 weeks ago
•? Previous local therapies of pancreatic cancer (radiotherapy, cryotherapy, etc.)
•? Contraindications for general anesthesia
•? Contraindications for systemic chemotherapy
•? Patient with impaired coagulation (Platelet count <75 x 10^9 / L; Quick <50%)

发起方

niversitätsklinikum Bonn