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

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

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).

Study Overview

• Status: Terminated
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Radiation: SBRT; Drug: SOC chemotherapy

Detailed 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 Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Heidelberg, Germany
    • University Hospital of Heidelberg, Dep. of Radiation Oncology
  • Bavaria
    • Munich, Bavaria, Germany, 81377
      • University of Munich, Dep. of Radiation Oncology
• Switzerland
  • Zurich, Switzerland
    • University Hospital of Zürich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A: SBRT; mPDAC patients not progressing after 8 weeks of standard of care systemic therapy (SoC-CT: minimum doublet chemotherapy). The primary tumor is treated with SBRT (6.6Gy x 5) on a MR-LINAC in breath-hold technique. 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.	Radiation: SBRT; online adaptive MR-guided hypofractionated stereotactic radiotherapy; Other Names: oMRgRT; Drug: SOC chemotherapy; The chemotherapy is given according to current standard of care, consisting of in minimum doublet - chemotherapy and excluding monotherapy regimens.
Active Comparator: Arm B: SOC; Continuing SoC-CT (according to clinical routine appr. 2 weeks after the previous cycle) without SBRT.	Drug: SOC chemotherapy; The chemotherapy is given according to current standard of care, consisting of in minimum doublet - chemotherapy and excluding monotherapy regimens.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	through study completion, at least 24 weeks or until death

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of biliary complications	Biliary complications defined as cholangitis or post-hepatic cholestasis requiring drainage	through study completion, at least 24 weeks or until death
Malnutrition	Nutritional status measuring bioimpedance-derived phase angle (BIA) every 12 weeks	through study completion, at least 24 weeks or until death
Treatment toxicity	Treatment toxicity according to CTCAE v5.0	through study completion, at least 24 weeks or until death
Death from any cause		through study completion

Collaborators and Investigators

• Sponsor: Ludwig-Maximilians - University of Munich
• Collaborators: University of Zurich; Heidelberg University
• Investigators: Principal Investigator: Maximilian Niyazi, Prof. Dr., Depatment of Radiation Oncology, University Hospital, LMU Munich

Publications and helpful links

General Publications

• Pavic M, Niyazi M, Wilke L, Corradini S, Vornhulz M, Mansmann U, Al Tawil A, Fritsch R, Horner-Rieber J, Debus J, Guckenberger M, Belka C, Mayerle J, Beyer G. 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). Radiat Oncol. 2022 Jan 25;17(1):18. doi: 10.1186/s13014-022-01988-6.

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2021
• Primary Completion (Actual): November 11, 2025
• Study Completion (Actual): November 11, 2025

Study Registration Dates

• First Submitted: October 16, 2021
• First Submitted That Met QC Criteria: October 29, 2021
• First Posted (Actual): November 9, 2021

Study Record Updates

• Last Update Posted (Actual): December 5, 2025
• Last Update Submitted That Met QC Criteria: November 30, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: chemotherapy; metastatic pancreatic cancer; SBRT; pain control; MR linac
• Additional Relevant MeSH Terms: Neurologic Manifestations; Endocrine System Diseases; Nervous System Diseases; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Neurobehavioral Manifestations; Endocrine Gland Neoplasms; Pancreatic Diseases; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pancreatic Neoplasms; Agnosia
• Other Study ID Numbers: 20-973

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No