At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed unresectable locally advanced or metastatic pancreatic adenocarcinoma eligible for treatment in first-line setting
- ✓Age ≥18 years
- ✓Measurable or non-measurable disease by CT/MRI per RECIST 1.1
- ✓Archival tumor sample available for biomarker analysis
- ✕Pancreatic neuroendocrine, acinar, squamous/adenosquamous, or islet cell tumors
- ✕Prior systemic therapy for advanced pancreatic adenocarcinoma
- ✕Major surgery or radiation within <4 weeks before randomization
- ✕Known allergy or hypersensitivity to study drugs
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Gemcitabine Plus Nab-PAclitaxel as Switch maiNTEnance Versus cONtinuation of Modified FOLFIRINOX as First-line Chemotherapy in Patients With Advanced Pancreatic Cancer: the PANThEON Phase III Trial
In Brief
A Phase 3 clinical trial evaluating Oxaliplatin, Irinotecan (CPT-11), and 4 other interventions for Pancreatic Adenocarcinoma Advanced or Metastatic. Currently recruiting, targeting 340 participants across 28 sites.
Detailed Summary
PANThEON is a randomized, open-label, multicenter phase III trial aimed at comparing the switch maintenance with gemcitabine plus nab-paclitaxel (ARM B) versus mFOLFIRINOX continuation (ARM A) in terms of overall survival (OS) in patients with unresectable LAD or mPDAC without disease progression following 3 months of induction mFOLFIRINOX triplet chemotherapy.
Study Details
Timeline
Interventions
85 mg/sqm iv over 2 hours day 1
150 mg/sqm iv over 60 minutes day 1
Leucovorin 400 mg/sqm (racemic) or l-Leucovorin 200 mg/sqm over 2 hours day 1
2400 mg/sqm 46-hours infusion
1000 mg/sqm over 30 minutes on Days 1,8,15 of a 28-day cycles
125 mg/sqm over 30 minutes on Days 1,8,15 of a 28-day cycles