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

Sponsor
Gruppo Oncologico del Nord-Ovest
Study ID
NCT06897644
Phase
PHASE3
Status
Recruiting
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Conditions

  • Pancreatic Adenocarcinoma Advanced or Metastatic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Oxaliplatin — DRUG
    85 mg/sqm iv over 2 hours day 1
  • Irinotecan (CPT-11) — DRUG
    150 mg/sqm iv over 60 minutes day 1
  • Leucovorin — DRUG
    Leucovorin 400 mg/sqm (racemic) or l-Leucovorin 200 mg/sqm over 2 hours day 1
  • 5-FU (5-fluorouracil) — DRUG
    2400 mg/sqm 46-hours infusion
  • gemcitabine — DRUG
    1000 mg/sqm over 30 minutes on Days 1,8,15 of a 28-day cycles
  • Nab-paclitaxel — DRUG
    125 mg/sqm over 30 minutes on Days 1,8,15 of a 28-day cycles

Study Details

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.

Key Dates

Start date
Mar 27, 2025
Status verified
May 2025
Primary completion
Jan 1, 2029
Completion
Jan 1, 2030

Study Design

Enrollment
340 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: ARM A - continuation of mFOLFIRINOX
    Patients in Arm A will receive continuation of the same regimen used as induction chemotherapy: * Oxaliplatin 85 mg/sqm; * Irinotecan 150 mg/sqm; * Leucovorin 400 mg/sqm (racemic) or l-Leucovorin 200 mg/sqm; * 5-FU 2400 mg/sqm 46-hours infusion; every 2 weeks. Treatment will continue until PD, unacceptable toxicity, informed consent withdrawal, or patient's death. In case of permanent discontinuation of one or more compounds due to unacceptable toxicity, treatment with the other agent(s) may be continued until PD.
  • Experimental: ARM B - switch maintenance with Gem-NabP
    Patients in Arm B will receive: * Gemcitabine 1000 mg/sqm on Days 1,8,15 of every 28-day cycles; * Nab-Paclitaxel 125 mg/sqm on Days 1,8,15 of every 28-day cycles. Treatment will continue until PD, unacceptable toxicity, informed consent withdrawal, or patient's death. In case of permanent discontinuation of one compound due to unacceptable toxicity, treatment with the other agent may be continued until PD in each arm.

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: from date of randomization to date of death (or last follow up for alive patients), assessed up to 48 months ]

Central Contacts

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