Skip to main content

Table 1 In- and exclusion criteria

From: MR-guided adaptive stereotactic body radiotherapy (SBRT) of primary tumor for pain control in metastatic pancreatic ductal adenocarcinoma (mPDAC): an open randomized, multicentric, parallel group clinical trial (MASPAC)

Inclusion criteria

Exclusion 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

Progressive disease after 8 weeks of SoC-CT

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

Previous pancreatic surgery

Previous abdominal radiotherapy of the upper abdomen

ECOG > 2

Patients with contraindications for MR imaging (e.g. non-MRI-compatible 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