2024-516260-29-00CompletedPhase 3
THE (COST)EFFECTIVENESS OF NEOADJUVANT FOLFIRINOX VERSUS NEOADJUVANT GEMCITABINE BASED CHEMORADIOTHERAPY AND ADJUVANT GEMCITABINE FOR (BORDERLINE) RESECTABLE PANCREATIC CANCER (PREOPANC-2 STUDY)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 9 Oct 2024
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 368 (actual)
- First submitted
- 23 Sept 2024
- Start date
- 10 Oct 2024
- Lead sponsor
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Diseases
- Pancreatic cancer
- EU CT number
- 2024-516260-29-00
- EudraCT number
- 2017-002036-17
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 368
- 17 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Previous malignancy (excluding non-melanoma skin cancer), unless no evidence of disease and diagnosed more than 2 years before diagnosis of pancreatic cancer.
Other
- Pregnancy
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (17)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Noordwest Ziekenhuisgroep Stichting | Alkmaar | Netherlands | Completed |
| Meander Medisch Centrum | Amersfoort | Netherlands | Completed |
| Amsterdam UMC Stichting | Amsterdam | Netherlands | Completed |
| Amphia Hospital | Breda | Netherlands | Completed |
| Reinier de Graaf Groep | Delft | Netherlands | Completed |
| Catharina Ziekenhuis Stichting | Eindhoven | Netherlands | Completed |
| Medisch Spectrum Twente | Enschede | Netherlands | Completed |
| Tjongerschans | Heerenveen | Netherlands | Completed |
| Leids Universitair Medisch Centrum (LUMC) | Leiden | Netherlands | Completed |
| Maastricht University Medical Center | Maastricht | Netherlands | Completed |
| Sint Antonius Ziekenhuis Stichting | Nieuwegein | Netherlands | Completed |
| Radboud universitair medisch centrum Stichting | Nijmegen | Netherlands | Completed |
| Maasstad Ziekenhuis Stichting | Rotterdam | Netherlands | Completed |
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) | Rotterdam | Netherlands | Completed |
| Jeroen Bosch Ziekenhuis Stichting | 'S-Hertogenbosch | Netherlands | Completed |
| Stichting Elisabeth-TweeSteden Ziekenhuis | Tilburg | Netherlands | Completed |
| Isala Klinieken Stichting | Zwolle | Netherlands | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.