Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruitment pending
Participants planned
378
Countries
2
Sites
22
Non-metastatic resectable pancreatic cancer
Investigate whether perioperative mFOLFIRINOX improves overall survival compared to adjuvant mFOLFIRINOX in resectable pancreatic cancer.
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]
- Decision date (initial)
- 2024-09-06
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-510617-15-00
- EudraCT number
- 2020-005141-16
- ClinicalTrials.gov
- NCT04927780
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
Investigate whether perioperative mFOLFIRINOX improves overall survival compared to adjuvant mFOLFIRINOX in resectable pancreatic cancer.
Conditions and MedDRA coding
Non-metastatic resectable pancreatic cancer
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 10
- Histologically or cytologically (Bethesda 5 or 6) confirmed pancreatic ductal adenocarcinoma
- 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
- No evidence for metastatic disease
- WHO performance status of 0 or 1
- Ability to undergo surgery and mFOLFIRINOX chemotherapy
- Leucocytes (WBC) ≥ 3.0 X 109/L
- Platelets ≥ 100X 109/L
- Hemoglobin ≥ 6.0 mmol/l
- Renal function: eGFR ≥ 40 ml/min
- Age ≥ 18 years
Exclusion criteria 5
- Prior radiotherapy, chemotherapy, or surgery for pancreatic cancer
- Prior chemotherapy precluding mFOLFIRINOX
- 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.
- Pregnancy or lactation
- 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
- Primary endpoint is overall survival by intention to treat
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 4
Irinotecan HCl-trihydraat Accord 20 mg/ml concentraat voor oplossing voor infusie
PRD11024052 · Product
- Active substance
- Irinotecan Hydrochloride Trihydrate
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 150 mg/m2 milligram(s)/square meter
- Max total dose
- 1800 mg/m2 milligram(s)/square meter
- Max treatment duration
- 38 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01CE02 — -
- Marketing authorisation
- RVG 117260
- MA holder
- ACCORD HEALTHCARE B.V.
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
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
- 1020 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 38 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
- 4800 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 38 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
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
- 1200 mg/m2 milligram(s)/square meter
- Max total dose
- 28800 mg/m2 milligram(s)/square meter
- Max treatment duration
- 38 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
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- 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
2 EU/EEA countries · 22 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Authorised, recruitment pending | 303 | 19 |
| Sweden | Authorised, recruitment pending | 75 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
Tjongerschans
Oncology, Thialfweg 44, 8441 PW, Heerenveen
Catharina Ziekenhuis Stichting
Department of Surgery, Michelangelolaan 2, 5623 EJ, Eindhoven
Isala Klinieken Stichting
Oncology, Dokter Van Heesweg 2, 8025 AB, Zwolle
Stichting OLVG
Department of Surgery, Oosterpark 9, 1091 AC, Amsterdam
Medisch Centrum Leeuwarden B.V.
Oncology, Henri Dunantweg 2, 8934 AD, Leeuwarden
Amsterdam UMC Stichting
Department of Surgery, De Boelelaan 1117, 1081 HV, Amsterdam
Leids Universitair Medisch Centrum (LUMC)
Department of Surgery, Albinusdreef 2, 2333 ZA, Leiden
Jeroen Bosch Ziekenhuis Stichting
Oncology, Henri Dunantstraat 1, 5223 GZ, 'S-Hertogenbosch
Universitair Medisch Centrum Groningen
Oncology, Hanzeplein 1, 9713 GZ, Groningen
Meander Medisch Centrum
Oncology, Maatweg 3, 3813 TZ, Amersfoort
Maasstad Ziekenhuis Stichting
Oncology, Maasstadweg 21, 3079 DZ, Rotterdam
Medisch Spectrum Twente
Department of Surgery, Koningsplein 1, 7512 KZ, Enschede
Deventer Ziekenhuis
Oncology, Nico Bolkesteinlaan 75, 7416 SE, Deventer
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department of Surgery, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Slingeland Ziekenhuis
Oncology, Kruisbergseweg 25, 7009 BL, Doetinchem
Amphia Hospital
Oncology, Molengracht 21, 4818 CK, Breda
St. Antonius Ziekenhuis
Department of Surgery, Koekoekslaan 1, 3435 CM, Nieuwegein
Academisch Ziekenhuis Maastricht
Oncology, P Debyelaan 25, 6229 HX, Maastricht
Radboud universitair medisch centrum Stichting
Department of Surgery, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
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.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_ Protocol 2024-510617-15-00 | 2.1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements Placeholder document | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements Placeholder document | 1 |
| Subject information and informed consent form (for publication) | E1-E2 PIF PREOPANC-3 Erasmus MC | 1.1 |
| Subject information and informed consent form (for publication) | Forskningspersonsinfo PREOPANC 3 | 1 |
| 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 Irinotecan | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_ SmPC Oxaliplatine | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-16 | Netherlands | Acceptable with conditions 2024-09-06
|
2024-09-06 |