Locally advanced pancreatic ductal adenocarcinoma Locally advanced pancreatic cancer
Conditions
Interventions
The study compares two established local treatment strategies:Surgical exploration with intent to resection, performed in high-volume expert centers according to standardized surgical protocols, follo
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Adults aged =18 years.Histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC), or strong clinical and radiological suspicion in case histological confirmation could not be obtained despite adequate attempts.Locally advanced pancreatic cancer (LAPC) according to the 2025 NCCN criteria.At least three months of systemic induction chemotherapy completed.Non-progressive disease on cross-sectional imaging after induction chemotherapy (RECIST).Favourable biological response after induction chemotherapy, defined as a =40% reduction in serum CA19-9 with an absolute value <500 U/mL, or alternative predefined metabolic criteria in case of non-elevated CA19-9.WHO/ECOG performance status 0–1 at restaging.Considered technically eligible for both surgical exploration and MRI-guided SABR according to the local multidisciplinary team.Absence of distant metastases confirmed before randomisation.Written informed consent provided.
Exclusion criteria
Exclusion criteria: Progressive disease during induction chemotherapy.Prior radiotherapy to the pancreas, except a single palliative fraction (8 Gy) for tumour-related bleeding.Clinical deterioration or increase in tumour-related pain during induction chemotherapy not attributable to other causes.Presence of distant metastases at restaging or during staging laparoscopy.Direct tumour invasion of gastrointestinal hollow organs other than the duodenum.History of another malignancy within the past three years, except adequately treated non-melanoma skin cancer or other malignancies with an expected life expectancy >5 years.Severe comorbidity or medical condition precluding surgery or radiotherapy.Inability to provide informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure is overall survival, defined as the time from randomization to death from any cause or last follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures include:Failure-free survival, defined as the absence of local or regional progression, distant metastases, second pancreatic cancer, or deathGlobal quality of life, functioning, symptom scores, and summary score assessed using the EORTC QLQ-C30 and PAN26 questionnaires during the first two years after randomizationSerious adverse events occurring within six months after randomizationIn-hospital and 90-day major morbidityClinically relevant pancreatic surgery–specific complicationsR0 resection rate in patients undergoing surgical resection | — |
Countries
China, Denmark, France, Germany, Italy, Netherlands
Contacts
Public ContactM G H Besselink
Amsterdam UMC
Outcome results
None listed