The (Cost)Effectiveness of Neoadjuvant Folfirinox Versus Neoadjuvant Gemcitabine Based Chemoradiotherapy and Adjuvant Gemcitabine for (Borderline) Resectable Pancreatic Cancer (PREOPANC-2 Study)

2024-516260-29-00 Therapeutic confirmatory (Phase III) Ended

Start 10 Oct 2024 · End 10 Sep 2025 · Status Ended · 1 EU/EEA countries · 17 sites

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)
Status Ended
Participants planned 368
Countries 1
Sites 17

non-metastatic (borderline) resectable pancreatic cancer

To determine whether neoadjuvant FOLFIRINOX followed by surgery improves overall survival and quality of life compared to neoadjuvant chemoradiotherapy followed by surgery and adjuvant gemcitabine in patients with (borderline) resectable pancreatic cancer in an intention-to-treat setting

Key facts

Sponsor
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Neoplasms [C04]
Trial duration
10 Oct 2024 → 10 Sep 2025
Decision date (initial)
2024-10-09
Transition trial
Yes
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No

External identifiers

EU CT number
2024-516260-29-00
EudraCT number
2017-002036-17

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To determine whether neoadjuvant FOLFIRINOX followed by surgery improves overall survival and quality of life compared to neoadjuvant chemoradiotherapy followed by surgery and adjuvant gemcitabine in patients with (borderline) resectable pancreatic cancer in an intention-to-treat setting

Conditions and MedDRA coding

non-metastatic (borderline) resectable pancreatic cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

  1. Histologically or cytologically confirmed pancreatic cancer (i.e. pancreatic ductal adenocarcinoma)
  2. (Borderline) resectable tumor without metastatic disease
  3. WHO performance status 0 or 1
  4. Ability to undergo surgery, chemoradiotherapy and chemotherapy
  5. Leucocytes (WBC) ≥ 3.0 X 109/l
  6. Platelets ≥ 100X 109 /l
  7. Hemoglobin ≥ 6 mmol/l
  8. Renal function: E-GFR > 50 ml/min
  9. Age ≥ 18 years
  10. Written informed consent

Exclusion criteria 5

  1. Prior radiotherapy, chemotherapy, or resection for pancreatic cancer
  2. Prior radiotherapy or chemotherapy precluding chemoradiotherapy or FOLFIRINOX
  3. Previous malignancy (excluding non-melanoma skin cancer), unless no evidence of disease and diagnosed more than 2 years before diagnosis of pancreatic cancer.
  4. Pregnancy
  5. 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 and secondary outcome measures (English text)

Primary endpoints 1

  1. The main endpoint is overall survival

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 4

Oxaliplatine Fresenius Kabi 5 mg/ml concentraat voor oplossing voor infusie

PRD409115 · Product

Active substance
Oxaliplatin
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INFUSION
Max daily dose
85 mg/m2 milligram(s)/sq. meter
Max total dose
680 mg/m2 milligram(s)/sq. meter
Max treatment duration
26 Week(s)
Authorisation status
Authorised
ATC code
L01XA03 — OXALIPLATIN
Marketing authorisation
RVG 100834
MA holder
FRESENIUS KABI NEDERLAND B.V.
MA country
Netherlands
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Folinezuur Sandoz 10 mg/ml, oplossing voor injectie

PRD768858 · Product

Active substance
Folinic Acid
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INFUSION
Max daily dose
400 mg/m2 milligram(s)/sq. meter
Max total dose
3200 mg/m2 milligram(s)/sq. meter
Max treatment duration
26 Week(s)
Authorisation status
Authorised
ATC code
V03AF03 — CALCIUM FOLINATE
Marketing authorisation
RVG 15827
MA holder
SANDOZ B.V.
MA country
Netherlands
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Irinotecan HCl-trihydraat Fresenius Kabi 20 mg/ml, concentraat voor oplossing voor infusie

PRD409025 · Product

Active substance
Irinotecan Hydrochloride Trihydrate
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INFUSION
Max daily dose
180 mg/m2 milligram(s)/sq. meter
Max total dose
1440 mg/m2 milligram(s)/sq. meter
Max treatment duration
26 Week(s)
Authorisation status
Authorised
ATC code
L01CE02 — -
Marketing authorisation
RVG 34947
MA holder
FRESENIUS KABI NEDERLAND B.V.
MA country
Netherlands
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Fluorouracil Accord 50 mg/ml, oplossing voor injectie of infusie

PRD1972829 · Product

Active substance
Fluorouracil
Substance synonyms
5-FLOUROURACIL, 5-FLUORO-1H-PYRIMIDINE-2,4-DIONE, 5-FLUOROURACIL, 5-FU
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INFUSION
Max daily dose
1600 mg/m2 milligram(s)/sq. meter
Max total dose
22400 mg/m2 milligram(s)/sq. meter
Max treatment duration
26 Week(s)
Authorisation status
Authorised
ATC code
L01BC02 — FLUOROURACIL
Marketing authorisation
RVG 100701
MA holder
ACCORD HEALTHCARE B.V.
MA country
Netherlands
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Comparator 1

Gemcitabine Sandoz 40 mg/ml, concentraat voor oplossing voor infusie

PRD768901 · Product

Active substance
Gemcitabine Hydrochloride
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INFUSION
Max daily dose
1000 mg/m2 milligram(s)/sq. meter
Max total dose
19000 mg/m2 milligram(s)/sq. meter
Max treatment duration
44 Week(s)
Authorisation status
Authorised
ATC code
L01BC05 — GEMCITABINE
Marketing authorisation
RVG 106596
MA holder
SANDOZ B.V.
MA country
Netherlands
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

94 Total trials 46 Recruiting 17 Ended
Academic / Non-commercial
Sponsor organisation
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Address
Dr. Molewaterplein 40
City
Rotterdam
Postcode
3015 GD
Country
Netherlands

Scientific contact point

Organisation
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Contact name
Secretariat HPB

Public contact point

Organisation
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Contact name
Secretariat HPB

Locations

1 EU/EEA country · 17 investigational sites

By country

CountryMS statusPlanned subjectsSites
Netherlands Ended 368 17
Rest of world — 0 —

Investigational sites

Netherlands

17 sites · Ended
Reinier de Graaf Groep
Medical Oncology, Reinier De Graafweg 5, 2625 AD, Delft
Amsterdam UMC Stichting
Surgery, De Boelelaan 1117, 1081 HV, Amsterdam
Noordwest Ziekenhuisgroep Stichting
Medical Oncology, Wilhelminalaan 12, 1815 JD, Alkmaar
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Surgery, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Stichting Elisabeth-Tweesteden Ziekenhuis
Medical Oncology, Hilvarenbeekseweg 60, 5022 GC, Tilburg
Leids Universitair Medisch Centrum (LUMC)
Surgery, Albinusdreef 2, 2333 ZA, Leiden
Radboud universitair medisch centrum Stichting
Surgery, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Amphia Hospital
Medical Oncology, Molengracht 21, 4818 CK, Breda
Medisch Spectrum Twente
Surgery, Koningsplein 1, 7512 KZ, Enschede
Sint Antonius Ziekenhuis Stichting
Surgery, Koekoekslaan 1, 3435 CM, Nieuwegein
Maastricht University Medical Center
Medical Oncology, P Debyelaan 25, 6229HX, Maastricht
Catharina Ziekenhuis Stichting
Surgery, Michelangelolaan 2, 5623 EJ, Eindhoven
Jeroen Bosch Ziekenhuis Stichting
Surgery, Henri Dunantstraat 1, 5223 GZ, 'S-Hertogenbosch
Isala Klinieken Stichting
Surgery, Dokter Van Heesweg 2, 8025 AB, Zwolle
Tjongerschans
Surgery, Thialfweg 44, 8441 PW, Heerenveen
Maasstad Ziekenhuis Stichting
Surgery, Maasstadweg 21, 3079 DZ, Rotterdam
Meander Medisch Centrum
Medical Oncology, P. O. Box 1502, 3800 BM, Amersfoort

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Netherlands 2024-10-10 2025-09-10 2024-10-10 2024-10-11

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 9 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_Protocol 2024-516260-29-00 5
Recruitment arrangements (for publication) K1_Recruitment arrangements Placeholder document 1
Subject information and informed consent form (for publication) L1_SIS and ICF [SIS and ICF adults] 5A
Subject information and informed consent form (for publication) L1_SIS and ICF extern [SIS and ICF adults] 5B
Summary of Product Characteristics (SmPC) (for publication) G2_ SmPC 5-Fluorouracil 5
Summary of Product Characteristics (SmPC) (for publication) G2_ SmPC Folinezuur 4
Summary of Product Characteristics (SmPC) (for publication) G2_ SmPC Gemcitabine 11
Summary of Product Characteristics (SmPC) (for publication) G2_ SmPC Irinotecan 1
Summary of Product Characteristics (SmPC) (for publication) G2_ SmPC Oxaliplatine 1

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-09-23 Netherlands Acceptable with conditions
2024-10-09
 2024-10-09