Locally Advanced Pancreatic Carcinoma (LAPC)Phase 3PREOPANC-4 RCTNCT07867873
Surgery Versus Stereotactic Ablative Radiotherapy for Patients With Locally Advanced Pancreatic Cancer With Favourable Biological Response Following Induction Chemotherapy
A Phase 3 study testing Pancreatic surgery and MRI guided stereotactic ablative radiotherapy in people with Locally Advanced Pancreatic Carcinoma (LAPC), run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).
Trial summary
The primary objective of this study is to assess the added value of surgical exploration with intention for resection compared to MRI guided stereotactic ablative radiotherapy (SABR) in improving overall survival in patients with locally advanced pancreatic carcinoma (LAPC) who show a favourable biological response to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Pancreatic Carcinoma (LAPC)
- What is being tested?
- Pancreatic surgery and MRI guided stereotactic ablative radiotherapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 1 Oct 2034
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Age: ≥18 years.
- Diagnosis:
- Patients diagnosed with pathology proven (WHO 6-7) LAPC according to the 2025 NCCN guideline. Of note, WHO-3 is allowed for inclusion in case of evidence for neoplasia by molecular analyses if cystic lesions are absent. Chemotherapy may be started without pathologyproof after a least two attempts via fine-needle biopsy if the patient has a high radiological and clinical suspicion for pancreatic adenocarcinoma and consensus has been reached in the responsible multidisciplinary conference. Furthermore, patients must meet the following established A-B-C parameters after at least three months systemic induction therapy:
- Anatomy:
- RECIST non-progressive disease on cross-sectional imaging;
- No radiological downstaging to a borderline resectable tumour;
Show all 19Show fewer
- Surgical resection seems potentially feasible according to the local multidisciplinary team*;
- Radiation is technically feasible according to the local multidisciplinary team;
- Biology:
- Serum CA19-9 reduction >40% with an absolute end value <300 U/mL after induction chemotherapy**.
- NB1. If non-elevated serum CA19-9 at diagnosis, metabolic response on 18F-FDG PET scan defined as ≥30% reduction of SUVmax if >4 at baseline#.
- NB2. If non-elevated serum CA19-9 at diagnosis** and on 18F-FDG PET scan an SUVmax ≤4 at baseline, non-elevated serum CEA at restaging is required (i.e., ≤5 ng/ml).
- NB3. If serum CA19-9 after chemotherapy is >150 U/ml, a negative staging laparoscopy is required prior to randomization (unless a staging laparoscopy was already performed prior to starting systemic therapy). This is based on the PREOPANC-4 cohort wherein such patients had a 23% risk of peritoneal metastases (vs. 5% with <150 U/ml).
- Condition:
- ECOG/WHO performance status 0-1 at restaging, being fit for surgery and chemotherapy
- NB. If a systemic treatment switch is performed in the setting of induction therapy with the indication of (biochemical) disease progression, restaging according to the above-mentioned criteria are performed with using the A-B-C features between the first- and second-line systemic induction therapy as baseline.
- Patients who require a resection of the superior mesenteric artery (SMA) are only allowed for inclusion by centres where this is routine practice, as evidenced by a volume of on average ≥15 SMA resections for periampullary cancer over the preceding three years, considering the high risks of complication-related mortality. This also means that patients with an SMA string sign (i.e. irregularity of the arterial wall) on cross-sectional imaging after systemic induction therapycannot be randomized at centers. At baseline, serum CA19-9 is measured with a total bilirubin as low as possible and measured as short as possible before the start of chemotherapy. At restaging, serum CA19-9 is ideally measured in the same lab due to different essays with widely diverging results.
- #Preferably, FDG-PET scan is performed with EARL reconstruction protocol 1 or 2.
- Informed consent: Competent and willing to provide informed consent in accordance with the requirements of the ethics committee.
Who cannot join
- Prior treatment: Prior systemic induction therapy combined with any type of radiother-apy. Radiotherapy is not used as induction therapy as it has not been proven beneficial and considering the potential increased risk of major morbidity, although particularly seen with external beam radiotherapy. The only other possible indication for radio-therapy that is allowed in this trial is a single fraction of 8 Gray in case of tumour bleed-ing.
- Metastatic disease: Presence of metastatic disease
- Comorbidities: Clinical deterioration during systemic induction therapy or increase of suspected tumour-related pain after excluding other potential causes of pain (e.g., pancreatitis, stent dysfunction).
- History of other malignancies: A past medical history of malignancy, except under the following conditions: no evidence of disease, diagnosis more than three years ago before the diagnosis of pancreatic cancer, and life expectancy of more than five years from date of inclusion. Of note, a past medical history of non-melanoma skin cancer, pancreatic neuroendocrine tumour <2 cm, and gastrointestinal stroma tumour (GIST), or any other cancer with a life expectancy beyond five years are no exclusion criteria. Lastly, lesions on CT thorax that are too small to characterize are not considered met-astatic disease. The last exclusion criterium is tumours directly invading gastrointestinal hollow organs, except the duodenum.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Surgery Versus Stereotactic Ablative Radiotherapy for Patients With Locally Advanced Pancreatic Cancer With Favourable Biological Response Following Induction Chemotherapy (PREOPANC-4 RCT): An International Randomized Trial
The primary objective of this study is to assess the added value of surgical exploration with intention for resection compared to MRI guided stereotactic ablative radiotherapy (SABR) in improving overall survival in patients with locally advanced pancreatic carcinoma (LAPC) who show a favourable biological response to systemic induction chemotherapy.
Read the detailed description
The current evidence on the added survival benefit of surgery after induction chemotherapy is limited by strong selection bias, and international guidelines state that the longterm survival benefit of surgery in locally advanced pancreatic carcinoma (LAPC) remains uncertain. In parallel, stereotactic ablative radiotherapy (SABR), particulary MRI guided SABR, had emerged as a promising less invasive alternaitve, achieving high local control rates with limited toxicity. Therefore, this international, multicentre, open-label, phase 3 superiority randomized clinical trial assesses whethersurgery improves overall survival as compared to MRI-guided SABR. Primary objective is overall survival, secondary objectives include evaluation of failure free survival, quality of life, and serious adverse events.
- Being tested
- Pancreatic surgery, MRI guided stereotactic ablative radiotherapy
- Keywords
- Locally advanced pancreatic carcinoma, surgery, radiotherapy, MRI-guided stereotactic ablative radiotherapy, stereotactic ablative radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pancreatic surgeryProcedure or surgery
Surgical exploration starts with a staging laparoscopy, unless already performed previsouly. Hereafter, exploration is typically performed via laparotomy. Although heterogeneity exist in surgical techniques, the following general surgical principles are considered state-of-the-art:
- Artery-first approach in case of potential arterial involvement
- Arterial divestment in case of radiological signs of (former) involvement without current signs of arterial wall ingrowth (and negative biopsy of peri-arterial tissue) during surgery to remove all (former) tumour tissue.
- In case of vascular reconstruction that requires a patch or interposition graft, an autol-ogous (e.g., veins, peritoneal / falciform patch, splenic artery) or biological (e.g., bovine patch) graft is strongly preferred over synthetic prosthesis
MRI guided stereotactic ablative radiotherapyRadiation
MRI-guided SABR must be initiated within four weeks after randomization and is delivered in a hypofractioned regimen of 50 Gy in five fractions of 10 Gy, prescribed to 95% of the planning target volume (PTV). Treatment will be administered on alternative days, two or three times per week, with an intended overall treatment duration of two weeks (i.e., 14 days). All patients will undergo an MR (and CT scan at the department's discretion) for radiotherapy planning. The gross tumour volume (GTV) will be defined based on those imaging datasets and the restaging imaging. A PTV margin of 3mm is applied.
Two MRI-guided SABR platforms are allowed. 1.5 Tesla MR-Linac and MRIdian system (0.35 Tesla MR-Linac). All patients will receive a proton pump inhibitor (oral) once daily during MRI-guided SABR, continued for three months afterwards to reduce gastrointestinal toxicity.
| Study group | Role | What they receive |
|---|---|---|
| Surgery | Experimental | Pancreatic surgery Receives: Procedure: Pancreatic surgery |
| MRI guided stereotactic ablative radiotherapy | Active comparator | MRI guided stereotactic ablative radiotherapy Receives: Radiation: MRI guided stereotactic ablative radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
This will be measured in days. Participants receive systemic induction therapy before randomization, with a minimum duration of 3 months but no fixed duration. Therefore, overall survival is measured from the date of randomization.
Measured: Measured from the date of randomization to the date of documented death by any cause or the date of last follow up, whichever occurs first, assessed up to at 5 years of randomization.
Secondary outcomes (4)
Failure free survival
To compare the failure free survival (FFS) between surgical exploration with intention for resection and MRI guided stereotactic ablative radiotherapy. Failure is defined as any of the following: local relapse/recurrence, local progression, regional relapse/recurrence, regional progression, development of distant metastases, or occurrence of a second primary pancreatic cancer.
Measured: FFS is measured in days from date of randomization to date of first documented failure (whichever occurs first). Participants without documented failure will be censored at the date of last follow-up. FFS will be assessed up to 5yrs after randomization
Quality of life
functioning, and symptoms scores and the summary score during the first two years from randomization, using the EORTC QLQ-C30 (version 3.0). The higher the score, means more complaints. Scale 1-4. 30 questions.
Measured: First two years from randomization
serious adverse events
defined following the NCI Common Terminology Criteria for Adverse Events (CTCAE) (version 5.0) (grade ≥III),71 expressed as the number of patients with serious adverse event(s), the number of events, and type of events.
Measured: Six-months serious adverse events (SAEs) that occur from randomization
Global quality of life
Functioning, and symptoms scores and the summary score during the first two years from randomization using the EORTC PAN26 questionnaires. The higher the score, the more complaints. Scale 1-4. 25 questions.
Measured: First two years from randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2034 (estimated)
- Study completion1 Oct 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Pancreatic Carcinoma (LAPC)Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Sponsor type
- University, hospital or other
- Collaborators
- Erasmus Medical Center, University Hospital Verona, Italy, University Hospital Heidelberg, Catharina Ziekenhuis Eindhoven, St. Antonius Hospital, Leiden University Medical Center, Radboud University Medical Center, University Medical Center Groningen, Maastricht University Medical Center, San Raffaele University Hospital, Italy, West China Hospital, Institut Paoli-Calmettes, University Hospital, Essen, Copenhagen University Hospital, Denmark, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, University Hospital Padova, University Hospital Ulm, Assistance Publique - Hôpitaux de Paris, Ruijin Hospital, Tubingen University Hospital
- Responsible party
- Principal investigator, M.G. Besselink, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Sterre de Vet, MD, Phd, Study director, AmsterdamUMCFloor Fabels, Md, Phd, Study director, EramusMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07867873
- Sponsor's protocol ID
- 2026.0299 - NL-010805 - R03773
- Acronym
- PREOPANC-4 RCT
- Status last verified
- Oct 2026
- First submitted
- 8 Sep 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data sharing between the participating parties will be covered in the Consortium Agreement. Data will be handled confidentially and coded. The handling of personal data will comply with the Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data (General Data Protection Regulation). A subject identification code list will be used to link the data to the subject. These codes will not be based on the patient initials and birth date. The coordinating investigator will safeguard the key to this code. The data will be kept for 15 years.
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgery Versus Stereotactic Ablative Radiotherapy for Patients With Locally Advanced Pancreatic Cancer With Favourable Biological Response Following Induction Chemotherapy (PREOPANC-4 RCT): An International Randomized Trial
- ClinicalTrials.gov ID
- NCT07867873
- Acronym / sponsor ID
- PREOPANC-4 RCT / 2026.0299 - NL-010805 - R03773
- Keywords
- Locally advanced pancreatic carcinoma, surgery, radiotherapy, MRI-guided stereotactic ablative radiotherapy, stereotactic ablative radiotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- Erasmus Medical Center, University Hospital Verona, Italy, University Hospital Heidelberg, Catharina Ziekenhuis Eindhoven, St. Antonius Hospital, Leiden University Medical Center, Radboud University Medical Center, University Medical Center Groningen, Maastricht University Medical Center, San Raffaele University Hospital, Italy, West China Hospital, Institut Paoli-Calmettes, University Hospital, Essen, Copenhagen University Hospital, Denmark, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, University Hospital Padova, University Hospital Ulm, Assistance Publique - Hôpitaux de Paris, Ruijin Hospital, Tubingen University Hospital
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2034 (estimated)
- Study completion
- 1 Oct 2034 (estimated)
- First posted
- 9 Oct 2026 (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 primary objective of this study is to assess the added value of surgical exploration with intention for resection compared to MRI guided stereotactic ablative radiotherapy (SABR) in improving overall survival in patients with locally advanced pancreatic carcinoma (LAPC) who show a favourable biological response to systemic induction chemotherapy.
Detailed description
The current evidence on the added survival benefit of surgery after induction chemotherapy is limited by strong selection bias, and international guidelines state that the longterm survival benefit of surgery in locally advanced pancreatic carcinoma (LAPC) remains uncertain. In parallel, stereotactic ablative radiotherapy (SABR), particulary MRI guided SABR, had emerged as a promising less invasive alternaitve, achieving high local control rates with limited toxicity. Therefore, this international, multicentre, open-label, phase 3 superiority randomized clinical trial assesses whethersurgery improves overall survival as compared to MRI-guided SABR. Primary objective is overall survival, secondary objectives include evaluation of failure free survival, quality of life, and serious adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery | Experimental | Procedure: Pancreatic surgeryPancreatic surgery |
| MRI guided stereotactic ablative radiotherapy | Active comparator | Radiation: MRI guided stereotactic ablative radiotherapyMRI guided stereotactic ablative radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Age: ≥18 years.
- Diagnosis:
- Patients diagnosed with pathology proven (WHO 6-7) LAPC according to the 2025 NCCN guideline. Of note, WHO-3 is allowed for inclusion in case of evidence for neoplasia by molecular analyses if cystic lesions are absent. Chemotherapy may be started without pathologyproof after a least two attempts via fine-needle biopsy if the patient has a high radiological and clinical suspicion for pancreatic adenocarcinoma and consensus has been reached in the responsible multidisciplinary conference. Furthermore, patients must meet the following established A-B-C parameters after at least three months systemic induction therapy:
- Anatomy:
- RECIST non-progressive disease on cross-sectional imaging;
Key exclusion criteria (4 listed)
- Prior treatment: Prior systemic induction therapy combined with any type of radiother-apy. Radiotherapy is not used as induction therapy as it has not been proven beneficial and considering the potential increased risk of major morbidity, although particularly seen with external beam radiotherapy. The only other possible indication for radio-therapy that is allowed in this trial is a single fraction of 8 Gray in case of tumour bleed-ing.
- Metastatic disease: Presence of metastatic disease
- Comorbidities: Clinical deterioration during systemic induction therapy or increase of suspected tumour-related pain after excluding other potential causes of pain (e.g., pancreatitis, stent dysfunction).
- History of other malignancies: A past medical history of malignancy, except under the following conditions: no evidence of disease, diagnosis more than three years ago before the diagnosis of pancreatic cancer, and life expectancy of more than five years from date of inclusion. Of note, a past medical history of non-melanoma skin cancer, pancreatic neuroendocrine tumour <2 cm, and gastrointestinal stroma tumour (GIST), or any other cancer with a life expectancy beyond five years are no exclusion criteria. Lastly, lesions on CT thorax that are too small to characterize are not considered met-astatic disease. The last exclusion criterium is tumours directly invading gastrointestinal hollow organs, except the duodenum.
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 |
|---|---|---|
| Pancreatic surgerySurgical exploration starts with a staging laparoscopy, unless already performed previsouly. Hereafter, exploration is typically performed via laparotomy. Although heterogeneity exist in surgical techniques, the following general surgical principles are considered state-of-the-art: 1. Artery-first approach in case of potential arterial involvement 2. Arterial divestment in case of radiological signs of (former) involvement without current signs of arterial wall ingrowth (and negative biopsy of peri-arterial tissue) during surgery to remove all (former) tumour tissue. 3. In case of vascular reconstruction that requires a patch or interposition graft, an autol-ogous (e.g., veins, peritoneal / falciform patch, splenic artery) or biological (e.g., bovine patch) graft is strongly preferred over synthetic prosthesis | Procedure or surgery | Surgery |
| MRI guided stereotactic ablative radiotherapyMRI-guided SABR must be initiated within four weeks after randomization and is delivered in a hypofractioned regimen of 50 Gy in five fractions of 10 Gy, prescribed to 95% of the planning target volume (PTV). Treatment will be administered on alternative days, two or three times per week, with an intended overall treatment duration of two weeks (i.e., 14 days). All patients will undergo an MR (and CT scan at the department's discretion) for radiotherapy planning. The gross tumour volume (GTV) will be defined based on those imaging datasets and the restaging imaging. A PTV margin of 3mm is applied. Two MRI-guided SABR platforms are allowed. 1.5 Tesla MR-Linac and MRIdian system (0.35 Tesla MR-Linac). All patients will receive a proton pump inhibitor (oral) once daily during MRI-guided SABR, continued for three months afterwards to reduce gastrointestinal toxicity. | Radiation | MRI guided stereotactic ablative radiotherapy |
Primary outcome
Overall survival
Time frame: Measured from the date of randomization to the date of documented death by any cause or the date of last follow up, whichever occurs first, assessed up to at 5 years of randomization.
This will be measured in days. Participants receive systemic induction therapy before randomization, with a minimum duration of 3 months but no fixed duration. Therefore, overall survival is measured from the date of randomization.
4 secondary outcomes
Failure free survival
Time frame: FFS is measured in days from date of randomization to date of first documented failure (whichever occurs first). Participants without documented failure will be censored at the date of last follow-up. FFS will be assessed up to 5yrs after randomization
Quality of life
Time frame: First two years from randomization
serious adverse events
Time frame: Six-months serious adverse events (SAEs) that occur from randomization
Global quality of life
Time frame: First two years from randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No. Data sharing between the participating parties will be covered in the Consortium Agreement. Data will be handled confidentially and coded. The handling of personal data will comply with the Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data (General Data Protection Regulation). A subject identification code list will be used to link the data to the subject. These codes will not be based on the patient initials and birth date. The coordinating investigator will safeguard the key to this code. The data will be kept for 15 years.
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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.
Sterre de Vet, MD, Phd study director
AmsterdamUMC
Floor Fabels, Md, Phd study director
EramusMC
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pancreatic surgery and MRI guided stereotactic ablative radiotherapy in people with Locally Advanced Pancreatic Carcinoma (LAPC), run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).
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 19 inclusion and 4 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: opening soon, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marc Besselink, Prof. MD, Phd, surgeon (+31616767330, m.g.besselink@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: Measured from the date of randomization to the date of documented death by any cause or the date of last follow up, whichever occurs first, assessed up to at 5 years of randomization.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Oct 2026.