C25
Conditions
Interventions
Group 1: MR-guided adaptive stereotactic body radiotherapy using MR-LINAC of primary tumor embedded in standard of care doublet chemotherapy
Group 2: Standard of care doublet chemotherapy without SBRT
Sponsors
LMU Klinikum
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Male and female patients with histologically proven, metastatic pancreatic adenocarcinoma of the pancreatic head or body amenable for MR-guided adaptive SBRT with at least stable disease after 8 weeks of standard of care doublet chemotherapy ? age >18 years ? Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1 or 2. ? Ability to follow study instructions and likely to attend and complete all required visits Written informed consent of the subject
Exclusion criteria
Exclusion criteria: Subjects not able to give consent ? Subjects without legal capacity who are unable to understand the nature, scope, significance and consequences of this clinical study ? Simultaneous participation in another clinical study or participation in any clinical trial involving an investigational medicinal product or treatment within 30 days prior to beginning of this study ? Subjects with a physical or psychiatric condition which at the investigator’s discretion may put the subject at risk, may confound the study results, or may interfere with the subject’s participation in this study Women of child bearing potential or sexually active males not willing to use effective contraception while on treatment and 12 weeks after the end of treatment (such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices) unless they are surgically sterilized / hysterectomized or there are any other criteria considered sufficiently reliable by the investigator in individual cases Exclusion criteria regarding special restrictions for females: ? Current or planned pregnancy or nursing women Indication-specific exclusion criteria: ? Previous pancreatic surgery ? Previous abdominal radiotherapy of the upper abdomen ? ECOG >2 ? Patients with contraindications for MRI imaging (e.g. non-MRIcompatible cardiac pacemaker or ICD / Cochlea implant / metal implants / severe claustrophobia) ? Patients with contraindications for doublet-chemotherapy ? Patients with contraindications for MR-guided adaptive SBRT ? Biopsy proven tumor invasion into the stomach and/or duodenum ? Concomitant non-pancreatic malignancy. Patients being treated for a non-pancreatic malignancy with tumor control for over 3 years are eligible. ? Medically uncontrolled pain
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| •Mean Cumulative pain index: AUC of pain scores rated every 4 weeks until death or end of study using numeric rating scale (NRS, 0= no pain, 10 = worst pain) divided by number of multiples of 4 weeks since randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| • Average pain on NRS at 24 weeks • Time until definitive deterioration (TUDD) defined as increase of average pain on NRS of 3 points over baseline sustained over 4 weeks. • Biliary complications defined as cholangitis or post-hepatic cholestasis requiring drainage. • Nutritional status measuring bioimpedance-derived phase angle (BIA) every 12 weeks • Death from any cause • Treatment toxicity according to CTCAE v5.0 • Quality of life (EQ-5D-5L, FACT-Hepatobiliary Symptom Index – FHSI-8) | — |
Countries
Germany, Switzerland
Contacts
Public ContactAnnette Vogel
Klinikum der Universität München, Campus Großhadern
Outcome results
None listed