Clinical trial • Phase III • Oncology

IRINOTECAN HYDROCHLORIDE TRIHYDRATE for Pancreatic ductal adenocarcinoma | Resectable non-metastatic pancreatic cancer

Phase III trial of IRINOTECAN HYDROCHLORIDE TRIHYDRATE for Pancreatic ductal adenocarcinoma | Resectable non-metastatic pancreatic cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Pancreatic ductal adenocarcinoma | Resectable non-metastatic pancreatic cancer
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
16-08-2024
First CTIS Authorization Date
06-09-2024

Trial design

Randomised, adjuvant mfolfirinox versus perioperative (neoadjuvant + peri-/adjuvant) mfolfirinox; dosing/schedule not specified in the ctis record-controlled Phase III trial across 22 sites in Netherlands, Sweden.

Randomised
Yes
Comparator
Adjuvant mFOLFIRINOX versus perioperative (neoadjuvant + peri-/adjuvant) mFOLFIRINOX; dosing/schedule not specified in the CTIS record
Target Sample Size
378

Eligibility

Recruits 378 Vulnerable population not selected (isVulnerablePopulationSelected=false); no special vulnerable-population consent/assent provisions are stated in the provided record..

Pregnancy Exclusion
Pregnancy or lactation
Vulnerable Population
Vulnerable population not selected (isVulnerablePopulationSelected=false); no special vulnerable-population consent/assent provisions are stated in the provided record.

Inclusion criteria

  • {"criterion_text":"- Histologically or cytologically (Bethesda 5 or 6) confirmed pancreatic ductal adenocarcinoma\n- Resectable tumor according to DPCG criteria: no arterial contact and venous contact with the superior mesenteric vein or portal vein of 90 degrees or less\n- No evidence for metastatic disease\n- WHO performance status of 0 or 1\n- Ability to undergo surgery and mFOLFIRINOX chemotherapy\n- Leucocytes (WBC) ≥ 3.0 X 109/L\n- Platelets ≥ 100X 109/L\n- Hemoglobin ≥ 6.0 mmol/l\n- Renal function: eGFR ≥ 40 ml/min\n- Age ≥ 18 years"}

Exclusion criteria

  • {"criterion_text":"- Prior radiotherapy, chemotherapy, or surgery for pancreatic cancer\n- Prior chemotherapy precluding mFOLFIRINOX\n- Previous malignancy (excluding non-melanoma skin cancer, pancreatic neuroendocrine tumor (pNET) <2cm, and gastrointestinal stromal tumor (GIST) <2cm), unless no evidence of disease and diagnosed more than 3 years before diagnosis of pancreatic cancer, or with a life expectancy of more than 5 years from date of inclusion.\n- Pregnancy or lactation\n- Serious concomitant systemic disorders that would compromise the safety of the patient or his/her ability to complete the study, at the discretion of the investigator"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Primary endpoint is overall survival by intention to treat","definition_or_measurement_approach":"Overall survival assessed using an intention-to-treat analysis"}

Recruitment

Planned Sample Size
378
Recruitment Window Months
55
Consent Approach
Informed consent required from adult participants; subject information and informed consent forms are listed in the CTIS documents ('Forskningspersonsinfo PREOPANC 3' and 'E1-E2 PIF PREOPANC-3 Erasmus MC'). No assent or minor consent provisions are stated; age criterion is ≥ 18 years.

Geography

Total Number Of Sites
22
Total Number Of Participants
378

Netherlands

Earliest CTIS Part Ii Submission Date
29-08-2024
Latest Decision Or Authorization Date
06-09-2024
Processing Time Days
8
Number Of Sites
19
Number Of Participants
303

Sites

Site Name
Deventer Ziekenhuis
Department Name
Oncology
Contact Person Name
A. Imholz
Contact Person Email
wetenschapsbureau@dz.nl
Site Name
Medisch Centrum Leeuwarden B.V.
Department Name
Oncology
Contact Person Name
M. Polee
Contact Person Email
Wetenschap@mclacademie.nl
Site Name
Isala Klinieken Stichting
Department Name
Oncology
Contact Person Name
J Groot
Contact Person Email
j.w.b.de.groot@isala.nl
Site Name
Maasstad Ziekenhuis Stichting
Department Name
Oncology
Contact Person Name
B Haberkorn
Site Name
Stichting OLVG
Department Name
Department of Surgery
Contact Person Name
T Karsten
Contact Person Email
T.M.Karsten@olvg.nl
Site Name
Amsterdam UMC Stichting
Department Name
Department of Surgery
Contact Person Name
Marc Besselink
Contact Person Email
ctis@amsterdamumc.nl
Site Name
Slingeland Ziekenhuis
Department Name
Oncology
Contact Person Name
R Wetering
Site Name
Radboud universitair medisch centrum Stichting
Department Name
Department of Surgery
Contact Person Name
M van der Kolk
Site Name
Leids Universitair Medisch Centrum (LUMC)
Department Name
Department of Surgery
Contact Person Name
Bert Bonsing
Contact Person Email
b.a.hoogland@lumc.nl
Site Name
Amphia Hospital
Department Name
Oncology
Contact Person Name
Mirte Streppel
Contact Person Email
mstreppel@amphia.nl
Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
Department of Surgery
Contact Person Name
Bas Groot Koerkamp
Site Name
Tjongerschans
Department Name
Oncology
Contact Person Name
H. Bos
Contact Person Email
hovon@erasmusmc.nl
Site Name
Catharina Ziekenhuis Stichting
Department Name
Department of Surgery
Contact Person Name
I Hingh
Site Name
Universitair Medisch Centrum Groningen
Department Name
Oncology
Contact Person Name
d Groot
Contact Person Email
d.j.a.de.groot@umcg.nl
Site Name
Academisch Ziekenhuis Maastricht
Department Name
Oncology
Contact Person Name
J. de Vos
Contact Person Email
judith.de.vos@mumc.nl
Site Name
Medisch Spectrum Twente
Department Name
Department of Surgery
Contact Person Name
M Liem
Contact Person Email
ResearchOC@mst.nl
Site Name
Meander Medisch Centrum
Department Name
Oncology
Contact Person Name
Geert Cirkel
Contact Person Email
GA.Cirkel@meandermc.nl
Site Name
St. Antonius Ziekenhuis
Department Name
Department of Surgery
Contact Person Name
H.C. van Santvoort
Site Name
Jeroen Bosch Ziekenhuis Stichting
Department Name
Oncology
Contact Person Name
M Wumkes
Contact Person Email
m.wumkes@jbz.nl

Sweden

Earliest CTIS Part Ii Submission Date
29-08-2024
Latest Decision Or Authorization Date
09-09-2024
Processing Time Days
11
Number Of Sites
3
Number Of Participants
75

Sites

Site Name
Karolinska University Hospital
Department Name
Department of Surgery
Contact Person Name
P. Ghorbani
Site Name
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Department Name
Department of Surgery
Contact Person Name
Sven Bratlie
Contact Person Email
sara.s.larsson@vgregion.se
Site Name
Region Skane Skanes Universitetssjukhus
Department Name
Department of Surgery
Contact Person Name
Bodil Andersson
Contact Person Email
bobby.tingstedt@med.lu.se

Sponsor

Primary sponsor

Full Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Netherlands

Investigational products

Investigational Product Name
Irinotecan HCl-trihydraat Accord 20 mg/ml concentraat voor oplossing voor infusie
Active Substance
IRINOTECAN HYDROCHLORIDE TRIHYDRATE
Modality
Small molecule
Routes Of Administration
INFUSION
Route
INFUSION
Authorisation Status
Authorised (marketing authorisation number RVG 117260, NL)
Maximum Dose
150 mg/m2
Investigational Product Name
Oxaliplatine Fresenius Kabi 5 mg/ml concentraat voor oplossing voor infusie
Active Substance
OXALIPLATIN
Modality
Small molecule
Routes Of Administration
INFUSION
Route
INFUSION
Authorisation Status
Authorised (marketing authorisation number RVG 100834, NL)
Maximum Dose
85 mg/m2
Investigational Product Name
Folinezuur Sandoz 10 mg/ml, oplossing voor injectie
Active Substance
FOLINIC ACID
Modality
Small molecule
Routes Of Administration
INFUSION
Route
INFUSION
Authorisation Status
Authorised (marketing authorisation number RVG 15827, NL)
Maximum Dose
400 mg/m2
Investigational Product Name
Fluorouracil Accord 50 mg/ml, oplossing voor injectie of infusie
Active Substance
FLUOROURACIL
Modality
Small molecule
Routes Of Administration
INFUSION
Route
INFUSION
Authorisation Status
Authorised (marketing authorisation number RVG 100701, NL)
Maximum Dose
1200 mg/m2
Combination Treatment
Yes

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