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Can a genetic test choose the right chemo for pancreatic cancer?

NCT ID NCT05314998

Disease control Sponsor: John Neoptolemos Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time

Summary

This phase III trial tests whether a genetic signature can guide chemotherapy choice after surgery for pancreatic cancer. Patients are randomly assigned to receive either oxaliplatin-based or gemcitabine-based chemotherapy, chosen either by standard clinical criteria or by a transcriptomic signature. The goal is to see if the genetic approach improves disease-free survival, meaning the time before the cancer returns or the patient dies from any cause. The trial enrolls adults aged 18 to 79 who had complete surgical removal of their pancreatic tumor.

What this could mean

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

Active substance
Chemotherapy regimens: oxaliplatin-based (FOLFIRINOX) or gemcitabine-based, chosen by standard criteria or a genetic signature
What this could lead to
If successful, this could show that a genetic test helps doctors pick the right chemotherapy for each patient after pancreatic cancer surgery, potentially improving the time before the cancer returns.
What could go wrong
The trial is large but still experimental. The genetic signature may not improve outcomes, and chemotherapy carries side effects like fatigue, nausea, and nerve damage.

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 394 people

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

Started

Aug 2026

Expected to finish

Sep 2034

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 to 79 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 1. Histologically proven pancreatic ductal adenocarcinoma including variants, and pancreatic acinar cell carcinoma. 2. Patient had provided tumour tissue at resection for RNAseq. 3. Macroscopically complete resection (R0 or R1 resection). 4. Female and male Patients aged from 18 to 79 years. 5. WHO performance status 0-1. 6. No prior radiotherapy and no previous chemotherapy for pancreatic cancer. 7. Full recovery from surgery and patient able to receive chemotherapy: adequate oral nutrition of ≥ 1500 calories per day and free of significant nausea and vomiting. 8. Adequate hematologic function: Absolute neutrophil count ≥ 1,500 cells/mm3, platelets ≥ 100,000 cells/mm3 and haemoglobin ≥ 8 g/L (transfusion permitted). 9. Serum total bilirubin ≤ 1.5 times the institutional upper limit of normal. 10. Creatinine clearance ≥ 50 mL/min. 11. Patient of child-bearing potential (for female patient: study entry after a menstrual period and a negative pregnancy test) must agree to use highly effective methods of contraception during the study and for 6 months after the last study treatment for women and 6 months for men. 12. Intended interval since surgery between 21 and 84 days at date of randomization. 13. Public or private health insurance cover. 14. Ability of subject to understand character and individual consequences of the clinical trial. 15. Not legally incapacitated. 16. Written informed consent. Exclusion Criteria 1. Solid pseudopapillary neoplasm, neuroendocrine neoplasm, pancreatoblastoma, bile duct cancer, and ampullary cancer. 2. Distant metastases, including ascites or malignant pleural effusion. 3. Macroscopic incomplete tumour removal (R2 resection). 4. Post-operative CA 19-9 \> 180 U / ml before randomization on study. 5. Cardiomyopathy or congestive heart failure, NYHA III-IV or coronary heart disease symptoms. 6. Major comorbidity that may preclude the delivery of treatment or known active infection (HIV or untreated chronic hepatitis B or active hepatitis C) or uncontrolled diabetes. 7. Pre-existing neuropathy, Gilbert's disease or known genotype UGT1A1\*28 /\*28. 8. Inflammatory disease of the colon or rectum, or intestinal obstruction, or severe postoperative uncontrolled diarrhoea. 9. Known severe dihydropyrimidine dehydrogenase (DPD) deficiency (activity score \<1). There are clear guidelines for dose reductions for patients with a score of 1 and 1,5 (2 is normal activity) 10. Pregnancy and lactation. 11. Participation in other clinical trials or observation period of competing trials, respectively. 12. History of hypersensitivity or other known contraindication to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product. 13. Past or current history of other malignancies not curatively treated and without evidence of disease for more than 5 years, except for curatively treated basal cell carcinoma of the skin and in situ carcinoma of the cervix or bladder, or low/intermediate risk prostate cancer (Gleason score ≤7) with normal PSA levels. 14. Any other concurrent antineoplastic treatment including irradiation

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Conditions

The condition(s) this trial relates to.

pancreatic acinar cell carcinoma pancreatic ductal adenocarcinoma

As listed by the trial registrant

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

Pancreatic ductal adenocarcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    33 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Akademiska sjukhuset

    NOT_YET_RECRUITING

    Uppsala, Sweden

  • Caritasklinikum Saarbrücken St. Theresia

    NOT_YET_RECRUITING

    Saarbrücken, 66113, Germany

  • DIK Deggendorf, Onkologische Ambulanz

    NOT_YET_RECRUITING

    Deggendorf, 94469, Germany

  • Karolinska University Hospital

    NOT_YET_RECRUITING

    Huddinge, Sweden

  • Klinikum Rechts der Isar der TU München, Klinik und Poliklinik für Chirurgie

    NOT_YET_RECRUITING

    München, 81675, Germany

  • Klinikum der Universität München, AG Onkologie der Med Klinik III

    NOT_YET_RECRUITING

    München, 81377, Germany

  • Medizinische Hochschule Hannover, Klinik für Gastroenterologie, Hepatologie und Endokrinologie

    NOT_YET_RECRUITING

    Hanover, 30625, Germany

  • Norrlands universitetssjukhus

    NOT_YET_RECRUITING

    Umeå, Sweden

  • Skånes universitetssjukhus

    NOT_YET_RECRUITING

    Malmö, Sweden

  • St. Josef-Hospital, Klinikum der Ruhr-Universität Bochum, Abteilung für Hämatologie, Onkologie und Palliativmedizin, Studienambulanz

    NOT_YET_RECRUITING

    Bochum, 44791, Germany

  • UKSH Campus Kiel, Medizinische Klinik II

    NOT_YET_RECRUITING

    Kiel, 24105, Germany

  • Univeristätsklinikum Jena

    NOT_YET_RECRUITING

    Jena, 07743, Germany

  • Universitetssjukhuset

    NOT_YET_RECRUITING

    Linköping, Sweden

  • Universität Leipzig, Medizinische Fakultät, Klinik für Gastroenterologie, Hepatologie, Infektiologie und Pneumologie

    NOT_YET_RECRUITING

    Leipzig, 04103, Germany

  • Universitätsklinikum Aachen, Studienzentrum Viszeralmedizin Klinik für Allgemeine-, Viszeral und Transplatationschirurgie

    NOT_YET_RECRUITING

    Aachen, 52074, Germany

  • Universitätsklinikum Augsburg, III. medizinische Klinik

    NOT_YET_RECRUITING

    Augsburg, 86156, Germany

  • Universitätsklinikum Bonn, Chirurgische Abteilung

    NOT_YET_RECRUITING

    Bonn, 53127, Germany

  • Universitätsklinikum Carl Gustav Carus an der TU Dresden, Klinik und Poliklinik für Viszeral-, Thorax- und Gefäßchirurgie

    NOT_YET_RECRUITING

    Dresden, 01307, Germany

  • Universitätsklinikum Erlangen, Chirurgische Klinik Zentrum für klinische Studien

    NOT_YET_RECRUITING

    Erlangen, 91054, Germany

  • Universitätsklinikum Frankfurt, Klinik für Allgemein-, Viszeral- und Transplantationschirurgie,

    NOT_YET_RECRUITING

    Frankfurt, 60590, Germany

  • Universitätsklinikum Freiburg, Klinik für Allgemein und Viszeralchirurgie, Abteilung Chirurgie

    NOT_YET_RECRUITING

    Freiburg im Breisgau, 79106, Germany

  • Universitätsklinikum Halle (Saale), Klinik und Poliklinik für Innere Medizin I

    NOT_YET_RECRUITING

    Halle, 06120, Germany

  • Universitätsklinikum Hamburg Eppendort, Zentrum für operative Medizin, Klinik und Poliklinik für Allgemein-, Viszeral- und Thoraxchirurgie

    NOT_YET_RECRUITING

    Hamburg, 20246, Germany

  • Universitätsklinikum Heidelberg, Abteilung für Allgemein-, Viszeral- und Transplantationschirurgie und Nationales Zentrum für Tumorerkrankungen, Medizinische Onkologie

    RECRUITING

    Heidelberg, 69120, Germany

  • Universitätsklinikum Mannheim, II. medizinische Klinik, Klinik für Gastroenterologie, Hepatologie, Infektiologie und Ernährungsmedizin

    NOT_YET_RECRUITING

    Mannheim, 68167, Germany

  • Universitätsklinikum Marburg, Klinik für Innere Medizin, Gastroenterologie, Stoffwechsel und Endokrinologie

    NOT_YET_RECRUITING

    Marburg, 35043, Germany

  • Universitätsklinikum Regensburg, Klinik und Poliklinik für Chirurgie

    NOT_YET_RECRUITING

    Regensburg, 93053, Germany

  • Universitätsklinikum Schleswig-Holstein, Klinik für Chirurgie, Onkologisches Zentrum Campus Lübeck

    NOT_YET_RECRUITING

    Lübeck, 23538, Germany

  • Universitätsklinikum Ulm, Klinik für Innere Medizin I Gastroenterologie-Endokrinologie-, Nephrologie-, Ernährung und Stoffwechselkrankheiten

    NOT_YET_RECRUITING

    Ulm, 89081, Germany

  • Universitätsklinikum Würzburg, Medizinische Klinik und Poliklinik II Zentrum für Innere Medizin

    NOT_YET_RECRUITING

    Würzburg, 97080, Germany

  • Universitätsklinikum des Saarlandes, Klinik für Innere Medizin II und Klinik für Allgemeine Viszeral Gefäß und Kinderchirurgie

    NOT_YET_RECRUITING

    Homburg/Saar, 66421, Germany

  • Universitätsmedizin Rostock, Klinik III (Hämatologie, Onkologie, Palliativmedizin), Zentrum für Innere Medizin

    NOT_YET_RECRUITING

    Rostock, 18055, Germany

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz, I. medizinische Klinik, Klinik für Allgemein-, Viszeral- und Transplantationschirurgie

    NOT_YET_RECRUITING

    Mainz, 55131, Germany

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