MR-Guided Adaptive SBRT of Primary Tumor for Pain Control in Metastatic PDAC

• Status: Not yet recruiting
• Trial end date: 2024-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The MASPAC trial investigates the added benefit of MR-guided adaptive SBRT of the primary tumor embedded between standard chemotherapy cycles for pain control and prevention of pain in patients with metastatic PDAC (mPDAC).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ludwig-Maximilians - University of Munich
• Collaborators: Heidelberg University; University of Zurich

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

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

• Biopsy proven tumor invasion into the stomach and/or duodenum

• Medically uncontrolled pain