Clinical trial • Phase III • Oncology

Fluorouracil for Pancreatic ductal adenocarcinoma (resected)

Phase III trial of Fluorouracil for Pancreatic ductal adenocarcinoma (resected).

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Pancreatic ductal adenocarcinoma (resected)
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
07-10-2024
First CTIS Authorization Date
06-11-2024

Trial design

Randomised, open-label, oxaliplatin-based chemotherapy arm versus gemcitabine-based chemotherapy arm; allocation performed either by standard clinical criteria or by a transcriptomic treatment specific signature (tss). specific drug doses and schedules are not specified in the available ctis data.-controlled Phase III trial across 39 sites in Germany, Sweden.

Randomised
Yes
Open Label
Yes
Comparator
Oxaliplatin-based chemotherapy arm versus Gemcitabine-based chemotherapy arm; allocation performed either by standard clinical criteria or by a transcriptomic treatment specific signature (TSS). Specific drug doses and schedules are not specified in the available CTIS data.
Biomarker Stratified
True, biomarker: Transcriptomic Treatment Signature (TSS); strata: allocation by TSS-defined treatment groups versus allocation by standard clinical criteria
Target Sample Size
394
Trial Duration For Participant
730

Eligibility

Recruits 394 Vulnerable population flag is selected in the application. Inclusion/consent related criteria state: "Ability of subject to understand character and individual consequences of the clinical trial.", "Not legally incapacitated.", and "Written informed consent must be available before enrolment in the trial." Consent is to be provided by the participant; no assent or parental consent provisions are mentioned in the available record..

Pregnancy Exclusion
Pregnancy and lactation.
Vulnerable Population
Vulnerable population flag is selected in the application. Inclusion/consent related criteria state: "Ability of subject to understand character and individual consequences of the clinical trial.", "Not legally incapacitated.", and "Written informed consent must be available before enrolment in the trial." Consent is to be provided by the participant; no assent or parental consent provisions are mentioned in the available record.

Inclusion criteria

  • {"criterion_text":"- Histologically proven pancreatic ductal adenocarcinoma including variants, and pancreatic acinar cell carcinoma.\n- Creatinine clearance ≥ 50 mL/min.\n- 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 intake for women and 6 months for men.\n- Intended interval since surgery between 21 and 84 days at date of randomization.\n- Public or private health insurance cover.\n- Ability of subject to understand character and individual consequences of the clinical trial.\n- Not legally incapacitated.\n- Written informed consent must be available before enrolment in the trial.\n- Patient had provided tumour tissue at resection for RNAseq\n- Macroscopically complete resection (R0 or R1 resection).\n- Female and male Patients aged from 18 to 79 years.\n- WHO performance status 0-1.\n- No prior radiotherapy and no previous chemotherapy for pancreatic cancer.\n- 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.\n- Adequate hematologic function: Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3, platelets ≥ 100,000 cells/mm3 and haemoglobin ≥ 8 g/L (transfusion permitted).\n- Serum total bilirubin ≤ 1.5 times the institutional upper limit of normal."}

Exclusion criteria

  • {"criterion_text":"- Solid pseudopapillary neoplasm, neuroendocrine neoplasm, pancreatoblastoma, bile duct cancer, and ampullary cancer.\n- Pregnancy and lactation.\n- Participation in other clinical trials or observation period of competing trials, respectively.\n- 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.\n- 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.\n- Any other concurrent antineoplastic treatment including irradiation.\n- Distant metastases, including ascites or malignant pleural effusion.\n- Macroscopic incomplete tumour removal (R2 resection).\n- Post-operative CA 19-9 >180 U / ml before randomization on study.\n- Cardiomyopathy or congestive heart failure, NYHA III-IV or coronary heart disease symptoms.\n- Major comorbidity that may preclude the delivery of treatment or known active infection (HIV or chronic hepatitis B or C) or uncontrolled diabetes.\n- Pre-existing neuropathy, Gilbert's disease or known genotype UGT1A1*28 /*28.\n- Inflammatory disease of the colon or rectum, or intestinal obstruction, or severe postoperative uncontrolled diarrhoea.\n- 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)."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Disease free survival, time from randomization to disease recurrence or death from any cause","definition_or_measurement_approach":"Time from randomization to documented disease recurrence or death from any cause (as stated: \"time from randomization to disease recurrence or death from any cause\")."}

Secondary endpoints

  • {"endpoint_text":"- Overall survival.","definition_or_measurement_approach":"Overall survival measured from randomization to death from any cause."}
  • {"endpoint_text":"- Metastasis free survival.","definition_or_measurement_approach":"Time to development of distant metastasis (as stated)."}
  • {"endpoint_text":"- Overall survival from recurrence.","definition_or_measurement_approach":"Overall survival measured from time of recurrence (as stated)."}
  • {"endpoint_text":"- Quality of life (EORTC QLQ C-30).","definition_or_measurement_approach":"Health-related quality of life assessed using the EORTC QLQ-C30 questionnaire."}
  • {"endpoint_text":"- Assessment of safety: i. Grade 3 and 4 toxicities according to NCI-CTC v.5.0. ii. Adverse and serious adverse events.","definition_or_measurement_approach":"Safety assessed by recording Grade 3 and 4 toxicities per NCI-CTC v5.0 and by monitoring adverse events and serious adverse events."}

Recruitment

Planned Sample Size
394
Recruitment Window Months
81
Consent Approach
Written informed consent must be available before enrolment in the trial. Eligibility requires subjects to be able to understand the trial and not be legally incapacitated. Subject information and informed consent forms are provided (document titles indicate German and Swedish versions are available). Participants (aged 18-79) provide consent themselves; no assent or parental consent procedures are described.

Geography

Total Number Of Sites
39
Total Number Of Participants
394

Germany

Earliest CTIS Part Ii Submission Date
23-10-2024
Latest Decision Or Authorization Date
16-12-2025
Processing Time Days
419
Number Of Sites
34
Number Of Participants
354

Sites

Site Name
Universitaetsklinikum Augsburg
Department Name
III med Klinik
Contact Person Name
Alexander Reichart
Site Name
Universitaetsklinikum des Saarlandes AöR
Department Name
Klinik für Allgemeine Viszeral Gefäß und Kinderchirurgie
Contact Person Name
Matthias Glanemann
Contact Person Email
matthias.glanemann@uks.eu
Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
Abteilung für Allgemeine, Viszerale und Transplantationschirurgie
Contact Person Name
Christoph Springfeld
Site Name
Caritas Traegergesellschaft Saarbruecken mbH (CTS)
Department Name
Medizinische Klinik - Gastroenterologie, Endokrinologie, Infektiologie
Contact Person Name
Manfred Paul Lutz
Contact Person Email
m.lutz@caritasklinik.de
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
Klinik und Poliklinik für Allgemein Viszeral und Thoraxchirurgie
Contact Person Name
Faik G. Uzunoglu
Contact Person Email
f.uzunoglu@uke.de
Site Name
Medizinisches Versorgungszentrum des Bruederkrankenhauses St. Josef Paderborn gGmbH
Department Name
Klinik für Hämatologie/ Onkologie
Contact Person Name
Muhannad Darkazanli
Contact Person Email
m.darkazanli@bbtgruppe.de
Site Name
St. Josef-Hospital
Department Name
Abt. für Hämatologie, Onkologie u. Palliativmedizin
Contact Person Name
Anke Reinacher-Schick
Contact Person Email
anke.reinacher@rub.de
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Klinik für Innere Medizin I
Contact Person Name
Thomas Theodor Werner Seufferlein
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Medizinische Klinik m. S. H
Contact Person Name
Uwe Pelzer
Contact Person Email
uwe.pelzer@charite.de
Site Name
Medical Center - University Of Freiburg
Department Name
Klinik für Allgemein- und Viszeralchirurgie Department Chirurgie
Contact Person Name
Dietrich Alexander Ruess
Site Name
Friedrich-Schiller-Universitaet Jena
Department Name
Klinik für Innere Medizin II
Contact Person Name
Udo Lindig
Contact Person Email
Udo.Lindig@med.uni-jena.de
Site Name
Universitaetsmedizin Goettingen
Department Name
Klinik für Allgemein Viszeral und Kinderchirurgie
Contact Person Name
Florian Bösch
Site Name
Universitaetsklinikum Frankfurt AöR
Department Name
Klinik für Allgemein-,Viszeral-, Transplantations- und Thoraxchirurgie
Contact Person Name
Ursula Pession
Contact Person Email
ursula.pession@kgu.de
Site Name
Medizinische Hochschule Hannover
Department Name
Klinik für Gastroenterologie Hepatologie und Endokrinologie
Contact Person Name
Anna Saborowski
Contact Person Email
saborowski.anna@mh-hannover.de
Site Name
Klinikum rechts der Isar der TU Muenchen AöR
Department Name
Klinik für Innere Medizin II
Contact Person Name
Maximilian Reichert
Contact Person Email
maximilian.reichert@tum.de
Site Name
Universitaetsklinikum Mannheim GmbH
Department Name
II. Medizinische Klinik
Contact Person Name
Nadine Schulte
Contact Person Email
nadine.schulte@umm.de
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Medizinische Klinik II Hämatologie und Onkologie
Contact Person Name
Anne Letsch
Contact Person Email
anne.letsch@uksh.de
Site Name
DONAUISAR Klinikum Deggendorf-Dingolfing-Landau gKU
Department Name
Onkologisches Zentrum
Contact Person Name
Matthias Behrend
Site Name
Kliniken der Stadt Koeln gGmbH
Department Name
Ambulanz für Hämatologie und Onkologie
Contact Person Name
Bernhard Alexander Sibbing
Contact Person Email
sibbingb@kliniken-koeln.de
Site Name
Universitaetsklinikum Aachen AöR
Department Name
Klinik für Allgemeine-, Viszeral und Transplatationschirurgie
Contact Person Name
Cennet Sahin
Contact Person Email
csahin@ukaachen.de
Site Name
Technische Universitaet Dresden
Department Name
Klinik und Poliklinik für Viszeral-, Thorax- und Gefäßchirurgie (VTG)
Contact Person Name
Ulrike Ubbelohde
Site Name
Universitaetsklinikum Bonn AöR
Department Name
Chirurgische Abteilung
Contact Person Name
Tim Rouwen Glowka
Contact Person Email
Tim.Glowka@ukbonn.de
Site Name
Rostock University Medical Center
Department Name
Medizinische Klinik III (Hämatologie, Onkologie, Palliativmedizin)
Contact Person Name
Hartmut Gläser
Site Name
University Of Luebeck
Department Name
Klinik für Hämatologie und Onkologie
Contact Person Name
Kim Barbara Luley
Contact Person Email
Kim.Luley@uksh.de
Site Name
Universitaetsklinikum Giessen und Marburg GmbH
Department Name
Klinik für Innere Medizin Gastroenterol Stoffwechsel und Endokrinologie
Contact Person Name
Malte Zumblick
Contact Person Email
zumblick@med.uni-marburg.de
Site Name
Friedrich Alexander Universitat Erlangen Nurnberg
Department Name
Allgemein und Viszeralchirurgie
Contact Person Name
Robert Grützmann
Site Name
Universitaetsklinikum Wuerzburg AöR
Department Name
Med. Klinik und Poliklinik II
Contact Person Name
Volker Kunzmann
Contact Person Email
kunzmann_v@ukw.de
Site Name
Krankenhaus Nordwest GmbH
Department Name
Institute of Clinical Cancer Research (IKF)
Contact Person Name
Thorsten Oliver Götze
Contact Person Email
Goetze.thorsten@khnw.de
Site Name
Rems-Murr-Kliniken gGmbH
Department Name
Hämatologie, Onkologie und Palliativmedizin
Contact Person Name
Henry Simon
Site Name
Universitaetsklinikum Leipzig AöR
Department Name
Klinik für Gastroenterologie, Hepatologie, Infektiologie und Pneumologie
Contact Person Name
Albrecht Hans Hoffmeister
Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
I Medizinische Klinik
Contact Person Name
Arndt Weinmann
Site Name
Klinikum der Universitaet Muenchen AöR
Department Name
Medizinische Klinik und Polikolnik II
Contact Person Name
Julia Mayerle
Site Name
Universitaetsklinikum Regensburg AöR
Department Name
Klinik und Poliklinik für Chirurgie
Contact Person Name
Hans J. Schlitt
Contact Person Email
Hans.Schlitt@ukr.de
Site Name
Universitaetsklinikum Halle (Saale) AöR
Department Name
Klinik und Poliklinik für Innere Medizin I
Contact Person Name
Petra Büchner-Steudel

Sweden

Earliest CTIS Part Ii Submission Date
23-10-2024
Latest Decision Or Authorization Date
15-12-2025
Processing Time Days
418
Number Of Sites
5
Number Of Participants
40

Sites

Site Name
Uppsala University Hospital
Department Name
Blod och tumörsjukdomar
Contact Person Name
Henning Karlsson
Contact Person Email
henning.karlsson@akademiska.se
Site Name
Region Oestergoetland
Department Name
Kirurgkliniken
Contact Person Name
Bergthor Björnson
Contact Person Email
region@regionostergotland.se
Site Name
Region Skane Skanes Universitetssjukhus
Department Name
VO hematologi, onklologi och strålningsfysik
Contact Person Name
Margareta Heby
Contact Person Email
margareta.heby@skane.se
Site Name
Karolinska University Hospital
Department Name
Tema cancer
Contact Person Name
Marco Gerling
Contact Person Email
marco.gerling@ki.se
Site Name
Region Vaesterbotten
Department Name
Cancercentrum
Contact Person Name
Daniel Öhlund
Contact Person Email
daniel.ohlund@umu.se

Sponsor

Primary sponsor

Full Name
Universitaetsklinikum Heidelberg AöR
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Germany

Third parties

  • {"country":"Germany","full_name":"Molecular Health GmbH","duties_or_roles":"Medical Device Guide for Targeted Drug Selection; contact: medical@molecularhealth.com","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Deutsches Krebsforschungszentrum Stiftung Des Oeffentlichen Rechts","duties_or_roles":"RNA/DNA Sequencing; Transcriptomic Treatment Signature; contact: cto@dkfz-heidelberg.de","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Germany","full_name":"Universitaetsklinikum Heidelberg AöR","duties_or_roles":"treatment randomisation; other sponsor duties (codes: 10, 15, 6 as listed)","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Germany","full_name":"Frankfurter Institut Fuer Klinische Krebsforschung IKF GmbH","duties_or_roles":"Sponsor organisation (sponsor duties codes: 1, 12, 7, 8); contact: espac6@ikf-khnw.de","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
FLUOROURACIL
Active Substance
Fluorouracil
Modality
Small molecule
Routes Of Administration
INTRAVENOUS USE
Route
Intravenous
Maximum Dose
1200 mg/m2 (max daily dose)
Investigational Product Name
OXALIPLATIN
Active Substance
Oxaliplatin
Modality
Small molecule
Routes Of Administration
INTRAVENOUS USE
Route
Intravenous
Maximum Dose
85 mg/m2 (max daily dose)
Investigational Product Name
IRINOTECAN
Active Substance
Irinotecan
Modality
Small molecule
Routes Of Administration
INTRAVENOUS USE
Route
Intravenous
Maximum Dose
150 mg/m2 (max daily dose)
Investigational Product Name
GEMCITABINE HYDROCHLORIDE
Active Substance
Gemcitabine hydrochloride
Modality
Small molecule
Routes Of Administration
INTRAVENOUS USE
Route
Intravenous
Maximum Dose
1000 mg/m2 (max daily dose)
Investigational Product Name
CAPECITABINE
Active Substance
Capecitabine
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
Oral
Maximum Dose
1660 mg/m2 (max daily dose)
Investigational Product Name
CALCIUM FOLINATE
Active Substance
Calcium folinate (Leucovorin calcium)
Modality
Small molecule
Routes Of Administration
INTRAVENOUS USE
Route
Intravenous
Maximum Dose
400 mg/m2 (max daily dose)
Combination Treatment
Yes

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