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

• Status: Not yet recruiting
• Trial end date: 2029-09-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: John Neoptolemos
• Collaborators: Deutsches Krebsforschungszentrum (DKFZ); Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest; Institute of Medical Biometry and Informatics; Molecular Health GmbH; Nationales Centrum für Tumorerkrankungen
• Treatments: Capecitabine; Fluorouracil; Folic Acid; Gemcitabine; Irinotecan; Leucovorin; Levoleucovorin; Oxaliplatin

Criteria

Inclusion Criteria

1. Histologically proven pancreatic ductal adenocarcinoma including variants, and 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.

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 4 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. CA 19-9> 180 U / ml within 21 days of registration 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 Dihydropyrimidine dehydrogenase (DPD) deficiency.

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