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

Pancreatic Cancer Clinical Trial

Official title:
MR-Guided Adaptive Stereotactic Body Radiotherapy (SBRT) of Primary Tumor for Pain Control in Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) - a Randomized, Controlled Clinical Study

Clinical Trial 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).

Clinical Trial Description

Patients not progressing after 8 weeks of standard of care systemic therapy (SoC-CT: minimum doublet chemotherapy) will be included and randomized between arm A, receiving MR-guided adaptive SBRT of the primary tumor combined with continuation of SoC-CT, and arm B, continuing SoC-CT without SBRT. Arm A: The primary tumor is treated with SBRT (6.6 Gy x 5) on a MR-LINAC in breath-hold technique. This scheme was shown to have a reasonable toxicity profile on a conventional LINAC. A low toxicity profile is even more important in patients with metastatic and therefore definitively incurable cancer. Therefore, treatment is performed on a MR-LINAC to deliver high doses to the tumor while keeping the toxicity profile as low as possible. For this purpose, daily adaptive planning is performed aiming to maintain stringent dose constraints for organs at risk (duodenum / stomach / bowel / kidney). Chemotherapy will be continued after SBRT. Arm B: Continuing SoC-CT (according to clinical routine appr. 2 weeks after the previous cycle) without SBRT. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05114213
Study type Interventional
Source Ludwig-Maximilians - University of Munich
Contact Georg Beyer, Dr.
Phone +4989440072391
Email Georg.Beyer@med.uni-muenchen.de
Status Recruiting
Phase Phase 2
Start date December 15, 2021
Completion date May 2024
View Details
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