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

NCT05114213 | Terminated Phase 2

• 1 other identifier: 20-973
• Study Type: interventional
• Target: 9
• Locations: 2 countries
• Sites: 3

Brief 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).

Conditions

Pancreatic Cancer

Keywords

metastatic pancreatic cancer; SBRT; MR linac; chemotherapy; pain control

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of biliary complications

  through study completion, at least 24 weeks or until death

• Malnutrition

  through study completion, at least 24 weeks or until death

• Treatment toxicity

  through study completion, at least 24 weeks or until death

• Death from any cause

  through study completion

Study Arms (2)

Arm A: SBRT

EXPERIMENTAL

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; Drug: SOC chemotherapy

Arm B: SOC

ACTIVE COMPARATOR

Continuing SoC-CT (according to clinical routine appr. 2 weeks after the previous cycle) without SBRT.

Drug: SOC chemotherapy

Interventions

SOC chemotherapy DRUG

The chemotherapy is given according to current standard of care, consisting of in minimum doublet - chemotherapy and excluding monotherapy regimens.

Arm A: SBRT; Arm B: SOC

SBRT RADIATION

online adaptive MR-guided hypofractionated stereotactic radiotherapy

Also known as: oMRgRT

Arm A: SBRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Heidelberg University: collaborator
• University of Zurich: collaborator
• Ludwig-Maximilians - University of Munich: lead

Study Sites (3)

University of Munich, Dep. of Radiation Oncology

Munich, Bavaria, 81377, Germany

Location

University Hospital of Heidelberg, Dep. of Radiation Oncology

Heidelberg, Germany

Location

University Hospital of Zurich

Zurich, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 35078490 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms; Agnosia

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Maximilian Niyazi, Prof. Dr.

  Depatment of Radiation Oncology, University Hospital, LMU Munich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chair

Study Record Dates

• First Submitted: October 16, 2021
• First Posted: November 9, 2021
• Study Start: December 15, 2021
• Primary Completion: November 11, 2025
• Study Completion: November 11, 2025
• Last Updated: December 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2); CH (1)