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
- Conditions
- C25Malignant neoplasm of pancreas
- Registration Number
- DRKS00012367
- Lead Sponsor
- niversitätsklinikum Bonn
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
• 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
? ECOG= 3
? 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%)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method