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).
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
9
online adaptive MR-guided hypofractionated stereotactic radiotherapy
The chemotherapy is given according to current standard of care, consisting of in minimum doublet - chemotherapy and excluding monotherapy regimens.
University of Munich, Dep. of Radiation Oncology
Munich, Bavaria, Germany
University Hospital of Heidelberg, Dep. of Radiation Oncology
Heidelberg, Germany
University Hospital of Zurich
Zurich, Switzerland
Mean cumulative pain index
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
Time frame: through study completion, at least 24 weeks or until death
Number of biliary complications
Biliary complications defined as cholangitis or post-hepatic cholestasis requiring drainage
Time frame: through study completion, at least 24 weeks or until death
Malnutrition
Nutritional status measuring bioimpedance-derived phase angle (BIA) every 12 weeks
Time frame: through study completion, at least 24 weeks or until death
Treatment toxicity
Treatment toxicity according to CTCAE v5.0
Time frame: through study completion, at least 24 weeks or until death
Death from any cause
Time frame: through study completion
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