Status:
NOT_YET_RECRUITING
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
Lead Sponsor:
John Neoptolemos
Collaborating Sponsors:
Molecular Health GmbH
German Cancer Research Center
Conditions:
Pancreatic Ductal Adenocarcinoma
Eligibility:
All Genders
18-79 years
Phase:
PHASE3
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...
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 chemo...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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.
- 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.
- Exclusion Criteria
- 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.
- 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
Exclusion
Key Trial Info
Start Date :
January 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2031
Estimated Enrollment :
394 Patients enrolled
Trial Details
Trial ID
NCT05314998
Start Date
January 15 2025
End Date
September 1 2031
Last Update
December 10 2024
Active Locations (33)
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1
Universitätsklinikum Aachen, Studienzentrum Viszeralmedizin Klinik für Allgemeine-, Viszeral und Transplatationschirurgie
Aachen, Germany, 52074
2
Universitätsklinikum Augsburg, III. medizinische Klinik
Augsburg, Germany, 86156
3
St. Josef-Hospital, Klinikum der Ruhr-Universität Bochum, Abteilung für Hämatologie, Onkologie und Palliativmedizin, Studienambulanz
Bochum, Germany, 44791
4
Universitätsklinikum Bonn, Chirurgische Abteilung
Bonn, Germany, 53127