C25
Conditions
Interventions
Group 1: Patients receive palliative first-line standard chemotherapy according to standard protocol and clinical decision (gemcitabine as monotherapy, gemcitabine in combination with nab-paclitaxel,
Sponsors
Universitätsklinikum Bonn
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • 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)
Exclusion criteria
Exclusion criteria: ? 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%)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and feasibility: assessment of the tolerability of HIFU treatment in combination with standard chemotherapy in patients with inoperable pancreatic cancer based on the number of adverse events occurring | — |
Secondary
| Measure | Time frame |
|---|---|
| Symptom / pain control: Assessment of symptom / pain control: health status and quality of life (EORTC QLQ-C30), changes of analgesic medication, pain (VAS: visual analog scale, NRS: numerical rating score, BPI Brief pain inventory questionnaire) Local tumor control: evaluation of local tumor control following HIFU by measuring tumor sizes in 3 planes in MRI, CT and CEUS | — |
Countries
Germany
Contacts
Public ContactJulia Fazaal
Klinik und Poliklinik für Nuklearmedizin, Universitätskliniken Bonn
Outcome results
None listed