Neoadjuvant Triple Treatment for Borderline Resectable Pancreatic Cancer (PREOPANC-5)

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

66

Participants

Timeline

Start Date

September 23, 2024

Primary Completion Date

March 31, 2028

Study Completion Date

March 31, 2028

Conditions
Borderline Resectable Pancreatic Cancer
Interventions
DRUG

Pembrolizumab

Pembrolizumab 400 mg will be administered as a 30 minute IV infusion every 6 weeks.

DRUG

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).

RADIATION

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.

Trial Locations (4)

Unknown

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

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Maastricht University Medical Center

OTHER

collaborator

Erasmus Medical Center

OTHER

collaborator

St. Antonius Hospital

OTHER

lead

Amsterdam UMC, location VUmc

OTHER

NCT06384560 - Neoadjuvant Triple Treatment for Borderline Resectable Pancreatic Cancer (PREOPANC-5) | Biotech Hunter | Biotech Hunter