THE (COST)EFFECTIVENESS OF NEOADJUVANT FOLFIRINOX VERSUS NEOADJUVANT GEMCITABINE BASED CHEMORADIOTHERAPY AND ADJUVANT GEMCITABINE FOR (BORDERLINE) RESECTABLE PANCREATIC CANCER (PREOPANC-2 STUDY)
Key facts
- Where
- 'S-Hertogenbosch, Alkmaar, Amersfoort, Amsterdam, Breda, Delft, Eindhoven, Enschede, Heerenveen, Leiden, Maastricht, Nieuwegein, Nijmegen, Rotterdam, Tilburg és Zwolle, HollandiaSee the 17 sites
- Phase
- 3. fázis
Where in Hollandia
- Jeroen Bosch Ziekenhuis Stichting'S-Hertogenbosch, HollandiaNo longer taking part
- Noordwest Ziekenhuisgroep StichtingAlkmaar, HollandiaNo longer taking part
- Meander Medisch CentrumAmersfoort, HollandiaNo longer taking part
- Amsterdam UMC StichtingAmsterdam, HollandiaNo longer taking part
- Amphia HospitalBreda, HollandiaNo longer taking part
- Reinier de Graaf GroepDelft, HollandiaNo longer taking part
- Catharina Ziekenhuis StichtingEindhoven, HollandiaNo longer taking part
- Medisch Spectrum TwenteEnschede, HollandiaNo longer taking part
- TjongerschansHeerenveen, HollandiaNo longer taking part
- Leids Universitair Medisch Centrum (LUMC)Leiden, HollandiaNo longer taking part
- Maastricht University Medical CenterMaastricht, HollandiaNo longer taking part
- Sint Antonius Ziekenhuis StichtingNieuwegein, HollandiaNo longer taking part
- Radboud universitair medisch centrum StichtingNijmegen, HollandiaNo longer taking part
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)Rotterdam, HollandiaNo longer taking part
- Maasstad Ziekenhuis StichtingRotterdam, HollandiaNo longer taking part
- Stichting Elisabeth-TweeSteden ZiekenhuisTilburg, HollandiaNo longer taking part
- Isala Klinieken StichtingZwolle, HollandiaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Trial code
- EU 2024-516260-29-00
- Record updated
- 2024. október 9.
- Original description
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 settingRead full original descriptionShow less
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
Inclusion: Histologically or cytologically confirmed pancreatic cancer (i.e. pancreatic ductal adenocarcinoma); Written informed consent; (Borderline) resectable tumor without metastatic disease; WHO performance status 0 or 1; Ability to undergo surgery, chemoradiotherapy and chemotherapy; Leucocytes (WBC) ≥ 3.0 X 109/l; Platelets ≥ 100X 109 /l; Hemoglobin ≥ 6 mmol/l; Renal function: E-GFR > 50 ml/min; Age ≥ 18 years.
Exclusion: Prior radiotherapy, chemotherapy, or resection for pancreatic cancer; Prior radiotherapy or chemotherapy precluding chemoradiotherapy or FOLFIRINOX; 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; Previous malignancy (excluding non-melanoma skin cancer), unless no evidence of disease and diagnosed more than 2 years before diagnosis of pancreatic cancer; Pregnancy.