AzTrials
AzTrials

Pancreatic Ductal AdenocarcinomaPhase 3NCT05314998

Adjuvant Trial in Patients With Resected PDAC Randomized to Allocation of Oxaliplatin- or Gemcitabine-based Chemotherapy by Standard Clinical Criteria or by a Transcriptomic Treatment Specific Stratification Signature

A Phase 3 study testing Oxaliplatin, Irinotecan and Folinic acid in people with Pancreatic Ductal Adenocarcinoma, run by John Neoptolemos at 33 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a multicentre open labelled phase III adjuvant trial of disease-free survival in patients with resected pancreatic ductal adenocarcinoma randomized to allocation of oxaliplatin- or gemcitabine-based chemotherapy by standard clinical criteria (control arm) or by a transcriptomic treatment specific… Read more about this study

Who is it for?
Ages 18 to 79 years
Conditions the study is for
Pancreatic Ductal Adenocarcinoma
What is being tested?
Oxaliplatin, Irinotecan and Folinic acid
Could I receive a placebo?
No, everyone receives an active treatment
How many people
394 participants
Where
33 sitesin 2 countries
Study dates
17 Aug 2026to 1 Sep 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 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically proven pancreatic ductal adenocarcinoma including variants, and pancreatic acinar cell carcinoma.
  • Patient had provided tumour tissue at resection for RNAseq.
  • Macroscopically complete resection (R0 or R1 resection).
  • Female and male Patients aged from 18 to 79 years.
  • WHO performance status 0-1.
  • No prior radiotherapy and no previous chemotherapy for pancreatic cancer.
Show all 16Show fewer
  • 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.
  • Adequate hematologic function: Absolute neutrophil count ≥ 1,500 cells/mm3, platelets ≥ 100,000 cells/mm3 and haemoglobin ≥ 8 g/L (transfusion permitted).
  • Serum total bilirubin ≤ 1.5 times the institutional upper limit of normal.
  • Creatinine clearance ≥ 50 mL/min.
  • 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.
  • Intended interval since surgery between 21 and 84 days at date of randomization.
  • Public or private health insurance cover.
  • Ability of subject to understand character and individual consequences of the clinical trial.
  • Not legally incapacitated.
  • Written informed consent.

Who cannot join

  • Solid pseudopapillary neoplasm, neuroendocrine neoplasm, pancreatoblastoma, bile duct cancer, and ampullary cancer.
  • Distant metastases, including ascites or malignant pleural effusion.
  • Macroscopic incomplete tumour removal (R2 resection).
  • Post-operative CA 19-9 > 180 U / ml before randomization on study.
  • Cardiomyopathy or congestive heart failure, NYHA III-IV or coronary heart disease symptoms.
  • 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.
Show all 14Show fewer
  • Pre-existing neuropathy, Gilbert's disease or known genotype UGT1A1*28 /*28.
  • Inflammatory disease of the colon or rectum, or intestinal obstruction, or severe postoperative uncontrolled diarrhoea.
  • 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)
  • Pregnancy and lactation.
  • Participation in other clinical trials or observation period of competing trials, respectively.
  • 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.
  • 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.
  • Any other concurrent antineoplastic treatment including irradiation

Trial locations and contacts

33 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

John Neoptolemos, Prof. Dr. contact

0049 6221 56-39020

john.neoptolemos@med.uni-heidelberg.de

Claudia Pauligk, Dr. contact

0049 69 6301 - 3906

pauligk.claudia@ikf-khnw.de

33 sites in 2 countries

Germany28 sites, 28 recruiting

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

    Aachen, 52074

    Not yet recruiting

  • Universitätsklinikum Augsburg, III. medizinische Klinik

    Augsburg, 86156

    Not yet recruiting

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

    Bochum, 44791

    Not yet recruiting

  • Universitätsklinikum Bonn, Chirurgische Abteilung

    Bonn, 53127

    Not yet recruiting

  • DIK Deggendorf, Onkologische Ambulanz

    Deggendorf, 94469

    Not yet recruiting

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

    Dresden, 01307

    Not yet recruiting

  • Universitätsklinikum Erlangen, Chirurgische Klinik Zentrum für klinische Studien

    Erlangen, 91054

    Not yet recruiting

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

    Frankfurt, 60590

    Not yet recruiting

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

    Freiburg im Breisgau, 79106

    Not yet recruiting

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

    Halle, 06120

    Not yet recruiting

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

    Hamburg, 20246

    Not yet recruiting

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

    Hanover, 30625

    Not yet recruiting

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

    Heidelberg, 69120

    Recruiting

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

    Homburg/Saar, 66421

    Not yet recruiting

  • Univeristätsklinikum Jena

    Jena, 07743

    Not yet recruiting

  • UKSH Campus Kiel, Medizinische Klinik II

    Kiel, 24105

    Not yet recruiting

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

    Leipzig, 04103

    Not yet recruiting

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

    Lübeck, 23538

    Not yet recruiting

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

    Mainz, 55131

    Not yet recruiting

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

    Mannheim, 68167

    Not yet recruiting

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

    Marburg, 35043

    Not yet recruiting

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

    München, 81377

    Not yet recruiting

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

    München, 81675

    Not yet recruiting

  • Universitätsklinikum Regensburg, Klinik und Poliklinik für Chirurgie

    Regensburg, 93053

    Not yet recruiting

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

    Rostock, 18055

    Not yet recruiting

  • Caritasklinikum Saarbrücken St. Theresia

    Saarbrücken, 66113

    Not yet recruiting

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

    Ulm, 89081

    Not yet recruiting

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

    Würzburg, 97080

    Not yet recruiting

Other trials in Germany

Sweden5 sites, 5 recruiting

  • Karolinska University Hospital

    Huddinge

    Marco Gerling, Dr., +46 812380000, marco.gerling@ki.se

    Not yet recruiting

  • Universitetssjukhuset

    Linköping

    Bergthor Björnson, Dr., +46 101030000, region@regionostergotland.se

    Not yet recruiting

  • Skånes universitetssjukhus

    Malmö

    Margareta Heby, Dr., +46 40331000, margareta.heby@skane.se

    Not yet recruiting

  • Norrlands universitetssjukhus

    Umeå

    Daniel Öhlund, Dr., +46 907850000, daniel.ohlund@umu.se

    Not yet recruiting

  • Akademiska sjukhuset

    Uppsala

    Henning Karlsson, Dr., +46 186110000, henning.karlsson@akademiska.se

    Not yet recruiting

Other trials in Sweden

About this study

Official title: An Open Labelled Phase III Adjuvant Trial of Disease-free Survival in Patients With Resected Pancreatic Ductal Adenocarcinoma Randomized to Allocation of Oxaliplatin- or Gemcitabine-based Chemotherapy by Standard Clinical Criteria or by a Transcriptomic Treatment Specific Stratification Signature

This is a multicentre open labelled phase III adjuvant trial of disease-free survival in patients with resected pancreatic ductal adenocarcinoma randomized to allocation of oxaliplatin- or gemcitabine-based chemotherapy by standard clinical criteria (control arm) or by a transcriptomic treatment specific stratification signature or TSS (test arm).

Read the detailed description

The main purpose and primary objective of the study is to determine whether disease free survival in patients with resected pancreatic ductal adenocarcinoma (PDAC) treated with standard adjuvant chemotherapy regimens (oxaliplatin- or gemcitabine-based), is superior using allocation based on a treatment specific signature (TSS), compared to the same chemotherapy regimens allocated according to standard clinical criteria.

Secondary objectives of the study are to assess overall survival (median, 3 year survival rate), metastasis free survival; survival based on targeted signatures (TSS) in test versus control arms, and survival using targeted therapies initially on relapse compared to standard first-line therapies on relapse.

In addition, ESPAC-6 optional translational research programme will obtain tumor specimens and blodd samples to identify biomarkers that may predict response to chemotherapy or relapse.

ESPAC-6 will also generate a biobank of matched patient-derived organoids (PDOs) to provide an experimentally tractable model system for the development and testing of biomarker-driven personalised therapies.

ESPAC-6 translational research programme, will also develop a longitudinal blood biobank to analyse clinically relevant circulating biomarkers, such as blood proteins, metabolites and/or circulating-free tumour DNA.

Being tested
Oxaliplatin, Irinotecan, Folinic acid, 5-fluorouracil, Gemcitabine
Keywords
Pancreatic Ductal Adenocarcinoma, PDAC, Adjuvant therapy, Transcriptomic signature

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OxaliplatinDrug

    85 mg/m2 D1 over 2 hours every; 14 days, 12 cycles, 24 weeks

  • IrinotecanDrug

    150 mg/m2 D1 over 90 minutes to begin 30 min after the Folinic acid infusion is started; every 14 days, 12 cycles, 24 weeks

  • Folinic acidDrug

    400 mg/m2 (racemic mixture) (or 200 mg/m2 if L-folinic acid is used), IV infusion over 2 hours; every 14 days, 12 cycles, 24 weeks

  • 5-fluorouracilDrug

    2.4 g/m2 IV continuous infusion over 46 hours (1200 mg/m2/ day); every 14 days, 12 cycles, 24 weeks

  • GemcitabineDrug

    1000mg/m2 is given as an IV infusion over 30 minutes; on day 1, 8 and 15 out of 28 days (= 1 cycle); Repeated 6 times (i.e., 6 cycles) for 24 weeks

  • CapecitabineDrug

    1660mg/m2/day in two divided doses administered orally for 21 days followed by 7 days' rest (one cycle) for six cycles i.e. 24 weeks

Study groups in NCT05314998
Study groupRoleWhat they receive
Test Arm A: mFOLFIRINOX or Gem/Cap according to transcriptomic treatment specific signatureExperimentalmFOLFIRINOX-therapy (5-FU, Folinic Acid, Irinotecan, Oxaliplatin) according to individual transcriptomic treatment specific signature or Gem/Cap-therapy (Gemcitabine and Capecitabine) according to individual transcriptomic treatment specific signature
Receives: Drug: Oxaliplatin; Drug: Irinotecan; Drug: Folinic acid; Drug: 5-fluorouracil; Drug: Gemcitabine; Drug: Capecitabine
Control Arm B: mFOLFIRINOX or Gem/Cap according to standard clinical criteriaActive comparatormFOLFIRINOX-therapy (5-FU, Folinic Acid, Irinotecan, Oxaliplatin) according to standard clinical criteria or Gem/Cap-therapy (Gemcitabine and Capecitabine) according to standard clinical criteria
Receives: Drug: Oxaliplatin; Drug: Irinotecan; Drug: Folinic acid; Drug: 5-fluorouracil; Drug: Gemcitabine; Drug: Capecitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease free survival

    Disease free survival will be defined as time from ramdomisation to disease recurrence (growth or metastasis) or death from any cause all patients fulfilling the in- and exclusion criteria.

    Measured: 76 months

Secondary outcomes (5)

  1. Overall survival

    Overall survival is defined as the time from randomization to death due to any cause. If a patient is lost to follow up, overall survival time is censored at the time of last contact.

    Measured: 76 months

  2. Metastasis free survival

    Metastasis free survival is defined as the time from randomization to detection of metastasis or death from any cause. The time of metastasis is defined as the date of metastasis determined and recorded by the Pancreas Tumour Board (Multidisciplinary Team).

    If the patient is eligible for first line therapy the recurrence must be performed by a positive biopsy or cytology.

    If a patient is lost to follow up, metastasis free survival time is censored at the time of last contact.

    Measured: 76 months

  3. Overall survival from recurrence

    Overall survival is defined as the time from recurrence to death due to any cause. If a patient is lost to follow up, overall survival time is censored at the time of last contact.

    Measured: 76 months

  4. Quality of life (QoL EORTC QLQ-C-30)

    QoL will be assessed by the EORTC QLQ-C30 questionnaire in its most current version every three months starting from V1.

    Measured: 76 months

  5. Safety: (serious) adverse events and Grade 3 and 4 toxicities according to NCI-CTC v.5.0.

    Safety assessments will include adverse events. The proportion of grade 3 and 4 toxicity will be compared across treatments using time to event methods and frequency counts. Adverse and serious adverse events are collected throughout the study and will be tabulated and compared between study arms.

    The analysis of all safety endpoints is conducted on the safety set, which contains all patients who received at least one cycle of treatment.

    Measured: 47 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2022
  2. Study start17 Aug 2026
  3. Primary completion1 Apr 2033 (estimated)
  4. Study completion1 Sep 2034 (estimated)

Resources

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
Model description
Therapeutic intervention of standard adjuvant chemotherapy comprising oxaliplatin- or gemcitabine-based regimens based on standard clinical criteria, compared to selection using a transcriptomic treatment specific signature and prediction model.
Masking
None (open label)
Enrolment
394 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05314998
Sponsor's protocol ID
ESPAC-6
Other IDs
AIO-PAK-0121/ass, 2020-004906-79
Status last verified
Aug 2026
First submitted
29 Mar 2022
Last updated
27 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Oxaliplatin, Irinotecan and Folinic acid in people with Pancreatic Ductal Adenocarcinoma, run by John Neoptolemos at 33 sites in 2 countries.

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 16 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in Germany, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

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 John Neoptolemos, Prof. Dr. (0049 6221 56-39020, john.neoptolemos@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease free survival (time frame: 76 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05314998.

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 27 Aug 2026.

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