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Gemcitabine Plus Nab-paclitaxel as Switch Maintenance Versus Continuation of Modified FOLFIRINOX as 1st Line Chemotherapy in Patients With Advanced Pancreatic Cancer.

NCT06897644 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 340

Last updated 2025-05-25

No results posted yet for this study

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.

Conditions

  • Pancreatic Adenocarcinoma Advanced or Metastatic

Interventions

DRUG

Oxaliplatin

85 mg/sqm iv over 2 hours day 1

DRUG

Irinotecan (CPT-11)

150 mg/sqm iv over 60 minutes day 1

DRUG

Leucovorin

Leucovorin 400 mg/sqm (racemic) or l-Leucovorin 200 mg/sqm over 2 hours day 1

DRUG

5-FU (5-fluorouracil)

2400 mg/sqm 46-hours infusion

DRUG

gemcitabine

1000 mg/sqm over 30 minutes on Days 1,8,15 of a 28-day cycles

DRUG

Nab-paclitaxel

125 mg/sqm over 30 minutes on Days 1,8,15 of a 28-day cycles

Sponsors & Collaborators

  • Rising Tide Foundation

    collaborator OTHER

  • Gruppo Oncologico del Nord-Ovest

    lead OTHER

Principal Investigators

  • Monica Niger, MD · Fondazione IRCCS Istituto Nazionale dei Tumori di Milano

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-27
Primary Completion
2029-01-01
Completion
2030-01-01

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06897644 on ClinicalTrials.gov