C25
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Locally advanced pancreatic cancer (LAPC) not suitable for resection after induction chemotherapy 2. Restaging without progression 3. ECOG performance status 0-2 4. Ca 19-9 =500 U/ml 5. Ability to understand the nature and individual consequences of the clinical trial and to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Evidence of metastatic disease or Ca 19-9 >500 U/ml 2. Duodenal or gastric luminal infiltration on endoscopic evaluation 3. Metal bile duct stenting 4. Previous abdominal radiotherapy 5. Pregnant or breast-feeding females 6. Patients with contraindications for magnet resonance imaging (MRI) (non-MRI-compatible cardiac pacemaker or ICD, Cochlea implant, metal implants, severe claustrophobia) 7. Contraindications for hyperthermia (e.g., implanted heatsensitive devices, abdominal aortic aneurysm, etc.) 8. Patients without legal capacity or unable to understand the nature, significance and consequences of the study 9. Simultaneous participation in other interventional trials which could interfere with this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the frequency of serious adverse events (SAE`s) associated with radiotherapy or hyperthermia, defined as Common Terminology Criteria for Adverse Events version 6.0 grade = 3 toxicity, measured from the start of radiotherapy to 12 months after radiotherapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| -Local control: Time from the start of radiotherapy to the first documented local recurrence - Freedom from distant progression (FFDP): Time from the start of radiotherapy to the first evidence of distant metastasis -Overall survival (OS): Time from the start of radiotherapy to death -Systemic therapy-free interval (STFI): Time from last systemic treatment before radiotherapy to the start of the next systemic treatment -Quality of life according to EORTC QLQ-C30 and PAN26 at baseline, at the end of radiotherapy and 3 and 12 months after the end of radiotherapy | — |
Countries
Germany
Contacts
Klinik und Poliklinik für Strahlentherapie und Radioonkologie