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Could chemo before surgery boost survival in pancreatic cancer?

NCT ID NCT02959879

What the study statuses mean

This study's is highlighted.

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether giving chemotherapy before surgery (neoadjuvant chemo) helps people with resectable pancreatic cancer live longer. 153 patients were randomly assigned to either standard surgery followed by chemo, or one of two chemo regimens (FOLFOX or FOLFIRINOX) before surgery. The goal was to see if the neoadjuvant approach improves survival and reduces cancer recurrence.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
chemotherapy (FOLFOX or FOLFIRINOX)
What this could lead to
If it works, giving chemotherapy before surgery could help more patients live longer and reduce the chance of cancer coming back.
What could go wrong
This is a phase 2 trial with only 153 participants, so results are not definitive. Chemotherapy before surgery may not improve outcomes and can cause side effects.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

153 people

The number who actually took part.

Started

Mar 2017

Finished

Aug 2023

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 to 85 years

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: * Histology-proven, adenocarcinoma of the pancreas. * Resectable adenocarcinoma (according to the NCCN classification 2014): absence of distant organ or distal lymph node metastases, absence of evidence of superior mesenteric vein (SMV) and portal vein distortion, tumour thrombus, or venous encasement, the existence of clear fat planes around the celiac axis, hepatic artery and superior mesenteric artery (SMA). Resectability is evaluated on arterial-phase and portal-phase IV contrast-enhanced multislice CT-scan of the pancreas (slice thickness: 2.5 mm), as evaluated in a multidisciplinary staff meeting including at least one radiologist and one expert surgeon. * No prior chemotherapy. * Age 18 years or over. * Ability to understand and willingness to consent to formal requirements for study participation * Provision of written informed consent prior to any study-specific screening procedures. Exclusion Criteria: * PDAC defined as "borderline", locally advanced, non-resectable or metastatic. * Prior cancer therapy for PDAC * Surgical or anaesthesiological contra-indications: non-controlled congestive heart failure - non-treated angina - recent myocardial infarction (in the previous year) - non-controlled arterial hypertension (SBP \>160 mm or DBP \> 100 mm, despite optimal drug treatment), long QT, major non-controlled infection, severe liver failure. * Any medical, psychological or social situation that (in the investigator's opinion) could limit (i) the patient's compliance with the protocol or (ii) the ability to obtain or interpret data. * Pregnant or breastfeeding women and women of child-bearing age not using effective means of contraception. * History or current evidence on physical examination of central nervous system disease or peripheral neuropathy ≥ grade 1, according to according to Common Terminology Criteria for Adverse Events (CTCAE) v.4.0. * Known hypersensitivity reaction to any of the components of study treatments. * Pregnancy (the absence of which must be confirmed in a ß-hCG test) or breast-feeding. * Any significant disease which, in the investigator's opinion, would exclude the patient from the study. * Patients having been included in a clinical trial within the previous 4 weeks or participating in another trial.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Rouen University Hospital

    Rouen, France