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Timing of chemo may boost survival in pancreatic cancer

NCT ID NCT04927780

Disease control Sponsor: Erasmus Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether giving chemotherapy both before and after surgery helps people with pancreatic cancer live longer compared to chemotherapy only after surgery. About 378 patients with resectable pancreatic cancer will be randomly assigned to one of two treatment schedules. The goal is to see if the combined approach improves overall survival.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 378 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2021

Expected to finish

Jul 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Histologically or cytologically (Bethesda 5 or 6) confirmed pancreatic ductal adenocarcinoma. * Resectable tumor according to Dutch Pancreatic Cancer Group criteria: no arterial contact and venous contact with the superior mesenteric vein or portal vein of 90 degrees or less * No evidence for metastatic disease * WHO performance status of 0 or 1 * Ability to undergo surgery and mFOLFIRINOX chemotherapy * Leucocytes (WBC) ≥ 3.0 x 10\^9/L * Platelets ≥ 100 x 10\^9/L * Hemoglobin ≥ 6.0 mmol/l * Renal function: eGFR ≥ 40 ml/min * Age ≥ 18 years * Written informed consent Exclusion Criteria: * Prior radiotherapy, chemotherapy, or surgery for pancreatic cancer. * Prior chemotherapy precluding mFOLFIRINOX. * Previous malignancy (excluding non-melanoma skin cancer, pancreatic neuroendocrine tumor (pNET) \<2cm, and gastrointestinal stromal tumor (GIST) \<2cm), unless no evidence of disease and diagnosed more than 3 years before diagnosis of pancreatic cancer, or with a life expectancy of more than 5 years from date of inclusion. * Pregnancy or lactation. * Serious concomitant systemic disorders that would compromise the safety of the patient or his/her ability to complete the study, at the discretion of the investigator.

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Conditions

The condition(s) this trial relates to.

malignant pancreatic neoplasm pancreatic adenocarcinoma pancreatic ductal adenocarcinoma pancreatic neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pancreatic cancer Pancreatic ductal adenocarcinoma Resectable pancreatic adenocarcinoma

Contacts and locations

Locations

  • Amphia Hospital

    Breda, Netherlands

  • Amsterdam UMC

    Amsterdam, Netherlands

  • Catharina Hospital

    Eindhoven, Netherlands

  • Deventer Hospital

    Deventer, Netherlands

  • Erasmus MC University Medical Center

    Rotterdam, Netherlands

  • Isala Hospital

    Zwolle, Netherlands

  • Jeroen Bosch Hospital

    's-Hertogenbosch, Netherlands

  • Karolinska University Hospital

    Stockholm, Sweden

  • Leiden University Medical Center

    Leiden, Netherlands

  • Maasstad Ziekenhuis

    Rotterdam, Netherlands

  • Maastricht UMC+

    Maastricht, Netherlands

  • Meander Medical Center

    Amersfoort, Netherlands

  • Medical Center Leeuwarden

    Leeuwarden, Netherlands

  • Medisch Spectrum Twente

    Enschede, Netherlands

  • OLVG

    Amsterdam, Netherlands

  • Radboud University Medical Center

    Nijmegen, Netherlands

  • Regional Academic Center Utrecht, Antonius Hospital

    Utrecht, Netherlands

  • Sahlgrenska University Hospital

    Gothenburg, Sweden

  • Skåne University Hospital

    Lund, Sweden

  • Tjongerschans Hospital

    Heerenveen, Netherlands

  • University Medical Center Groningen

    Groningen, Netherlands

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