Pancreatic CancerPhase 2MASPACNCT05114213
MR-Guided Adaptive SBRT of Primary Tumor for Pain Control in Metastatic PDAC
A Phase 2 study testing SBRT and SOC chemotherapy in people with Pancreatic Cancer, run by Ludwig-Maximilians - University of Munich at 3 sites in 2 countries.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- SBRT and SOC chemotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 15 Dec 2021to 11 Nov 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Germany2 sites
University Hospital of Heidelberg, Dep. of Radiation Oncology
Heidelberg
University of Munich, Dep. of Radiation Oncology
Munich, Bavaria, 81377
About this study
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
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).
Read the 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.
- Conditions
- Pancreatic Cancer
- Being tested
- SBRT, SOC chemotherapy
- Keywords
- metastatic pancreatic cancer, SBRT, MR linac, chemotherapy, pain control
- Medical subject headings
- Pancreatic Neoplasms, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBRTRadiation
Also called oMRgRT
online adaptive MR-guided hypofractionated stereotactic radiotherapy
SOC chemotherapyDrug
The chemotherapy is given according to current standard of care, consisting of in minimum doublet - chemotherapy and excluding monotherapy regimens.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: SOC chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: through study completion, at least 24 weeks or until death
Secondary outcomes (4)
Number of biliary complications
Biliary complications defined as cholangitis or post-hepatic cholestasis requiring drainage
Measured: through study completion, at least 24 weeks or until death
Malnutrition
Nutritional status measuring bioimpedance-derived phase angle (BIA) every 12 weeks
Measured: through study completion, at least 24 weeks or until death
Treatment toxicity
Treatment toxicity according to CTCAE v5.0
Measured: through study completion, at least 24 weeks or until death
Death from any cause
Measured: through study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start15 Dec 2021
- Primary completion11 Nov 2025
- Study completion11 Nov 2025
Why it stopped: Low accrual, close out in November 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- Heidelberg University, University of Zurich
- Responsible party
- Principal investigator, Prof. Dr. med. Dipl.-Phys. Maximilian Niyazi, Ludwig-Maximilians - University of Munich
- Investigators
- Maximilian Niyazi, Prof. Dr., Principal investigator, Depatment of Radiation Oncology, University Hospital, LMU Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05114213
- Sponsor's protocol ID
- 20-973
- Acronym
- MASPAC
- Status last verified
- Nov 2025
- First submitted
- 16 Oct 2021
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 35078490
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05114213
- Acronym / sponsor ID
- MASPAC / 20-973
- Conditions
- Pancreatic Cancer
- Keywords
- metastatic pancreatic cancer, SBRT, MR linac, chemotherapy, pain control
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accrual, close out in November 2025
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Collaborators
- Heidelberg University, University of Zurich
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 11 Nov 2025 (actual)
- Study completion
- 11 Nov 2025 (actual)
- First posted
- 9 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: SBRT | Experimental | Radiation: SBRT, Drug: SOC chemotherapymPDAC 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. |
| Arm B: SOC | Active comparator | Drug: SOC chemotherapyContinuing SoC-CT (according to clinical routine appr. 2 weeks after the previous cycle) without SBRT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SBRTAlso: oMRgRTonline adaptive MR-guided hypofractionated stereotactic radiotherapy | Radiation | Arm A: SBRT |
| SOC chemotherapyThe chemotherapy is given according to current standard of care, consisting of in minimum doublet - chemotherapy and excluding monotherapy regimens. | Drug | Arm A: SBRT, Arm B: SOC |
Primary outcome
Mean cumulative pain index
Time frame: through study completion, at least 24 weeks or until death
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
4 secondary outcomes
Number of biliary complications
Time frame: through study completion, at least 24 weeks or until death
Malnutrition
Time frame: through study completion, at least 24 weeks or until death
Treatment toxicity
Time frame: through study completion, at least 24 weeks or until death
Death from any cause
Time frame: through study completion
Results and safety
The study was stopped early (reason given: Low accrual, close out in November 2025). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Derived from this study: PubMed 35078490Pavic 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maximilian Niyazi, Prof. Dr. principal investigator
Depatment of Radiation Oncology, University Hospital, LMU Munich
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SBRT and SOC chemotherapy in people with Pancreatic Cancer, run by Ludwig-Maximilians - University of Munich at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Low accrual, close out in November 2025). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean cumulative pain index (time frame: through study completion, at least 24 weeks or until death). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05114213, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.