66
Participants
Start Date
September 23, 2024
Primary Completion Date
March 31, 2028
Study Completion Date
March 31, 2028
Pembrolizumab
Pembrolizumab 400 mg will be administered as a 30 minute IV infusion every 6 weeks.
Folfirinox
FOLFIRINOX is a combination of systemic chemotherapy agents. FOLFIRINOX consists of oxaliplatin at a dose of 85 mg/m2, given as a 2-hour intravenous infusion, immediately followed by leucovorin at a dose of 400 mg/m2 given as a 2-hour intravenous infusion, with the addition, after 30 minutes, of irinotecan at a dose of 150 mg/m2, given as a 90-minute intravenous infusion through a Y-connector. This treatment is followed by a continuous intravenous infusion of 2400 mg/m2 5-FU over a 46-hour period every 2 weeks. (The FOLFIRINOX given in the trial is the modified scheme, whereby the fluorouracil bolus at a dose of 400 mg/m2 is omitted and the irinotecan dose reduced to 150 mg/m2).
SABR
SABR will be delivered in an image-guided hypofractionated scheme of 5 fractions of 8 Gy (total 40 Gy), prescribed to 95% of the planning target volume (PTV). Treatment is delivered on five non-consecutive days.
RECRUITING
Amsterdam University Medical Center, Amsterdam
NOT_YET_RECRUITING
Maastricht University Medical Center, Maastricht
RECRUITING
St. Antonius Ziekenhuis, Nieuwegein
RECRUITING
Erasmus University Medical Center, Rotterdam
Collaborators (1)
Maastricht University Medical Center
OTHER
Erasmus Medical Center
OTHER
St. Antonius Hospital
OTHER
Amsterdam UMC, location VUmc
OTHER