NCT05314998 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
| NCT ID | NCT05314998 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | John Neoptolemos |
| Condition | Pancreatic Ductal Adenocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 394 participants |
| Start Date | 2026-08-17 |
| Primary Completion | 2033-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 394 participants in total. It began in 2026-08-17 with a primary completion date of 2033-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 stratification signature or TSS (test arm).
Eligibility Criteria
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
Contact & Investigator
John Neoptolemos, Prof. Dr.
STUDY DIRECTOR
Universität Heidelberg
Frequently Asked Questions
Who can join the NCT05314998 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 79 Years, studying Pancreatic Ductal Adenocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05314998 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 394 participants.
Is NCT05314998 currently recruiting?
Yes, NCT05314998 is actively recruiting participants. Contact the research team at john.neoptolemos@med.uni-heidelberg.de for enrollment information.
Where is the NCT05314998 trial being conducted?
This trial is being conducted at Aachen, Germany, Augsburg, Germany, Bochum, Germany, Bonn, Germany and 11 additional locations.
Who is sponsoring the NCT05314998 clinical trial?
NCT05314998 is sponsored by John Neoptolemos. The principal investigator is John Neoptolemos, Prof. Dr. at Universität Heidelberg. The trial plans to enroll 394 participants.