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NCT05314998

PHASE3

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

Sponsor: John Neoptolemos

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

18 Years - 79 Years

Study Type

INTERVENTIONAL

Enrollment

394

Start Date

2025-01-15

Completion Date

2031-09-01

Last Updated

2024-12-10

Healthy Volunteers

Conditions

Pancreatic Ductal Adenocarcinoma

Interventions

DRUG

Oxaliplatin

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

DRUG

Irinotecan

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

DRUG

Folinic acid

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

DRUG

5-fluorouracil

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

DRUG

Gemcitabine

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

DRUG

Capecitabine

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

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

Locations (33)

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

Aachen, Germany

Universitätsklinikum Augsburg, III. medizinische Klinik

Augsburg, Germany

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

Bochum, Germany

Universitätsklinikum Bonn, Chirurgische Abteilung

Bonn, Germany

DIK Deggendorf, Onkologische Ambulanz

Deggendorf, Germany

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

Dresden, Germany

Universitätsklinikum Erlangen, Chirurgische Klinik Zentrum für klinische Studien

Erlangen, Germany

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

Frankfurt, Germany

Universitätsklinikum Freiburg, Klinik für Allgemein und Viszeralchirurgie, Abteilung Chirurgie

Freiburg im Breisgau, Germany

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

Halle, Germany

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

Hamburg, Germany

Medizinische Hochschule Hannover, Klinik für Gastroenterologie, Hepatologie und Endokrinologie

Hanover, Germany

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

Heidelberg, Germany

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

Homburg/Saar, Germany

Univeristätsklinikum Jena

Jena, Germany

UKSH Campus Kiel, Medizinische Klinik II

Kiel, Germany

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

Leipzig, Germany

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

Lübeck, Germany

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

Mainz, Germany

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

Mannheim, Germany

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

Marburg, Germany

Klinikum der Universität München, AG Onkologie der Med Klinik III

München, Germany

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

München, Germany

Universitätsklinikum Regensburg, Klinik und Poliklinik für Chirurgie

Regensburg, Germany

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

Rostock, Germany

Caritasklinikum Saarbrücken St. Theresia

Saarbrücken, Germany

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

Ulm, Germany

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

Würzburg, Germany

Centralsjukhuset

Karlstad, Sweden

Universitetssjukhuset

Linköping, Sweden

Skånes universitetssjukhus

Lund, Sweden

Norrlands universitetssjukhus

Umeå, Sweden

Akademiska sjukhuset

Uppsala, Sweden

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (33)