RecruitingPhase 3NCT06897644

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

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

Sponsor

Gruppo Oncologico del Nord-Ovest

Enrollment

340 participants

Start Date

Mar 27, 2025

Study Type

INTERVENTIONAL

Conditions

Pancreatic Adenocarcinoma Advanced or Metastatic

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two chemotherapy maintenance strategies for patients with advanced pancreatic cancer who have already responded to or stabilized on a first-line treatment called FOLFIRINOX. One option is to switch to a different, potentially gentler regimen (gemcitabine plus nab-paclitaxel) for maintenance, while the other continues the original FOLFIRINOX regimen. The goal is to find out which approach keeps the cancer under control for longer while maintaining quality of life. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with advanced (unresectable or metastatic) pancreatic cancer, confirmed by biopsy - You are being treated in the first-line setting (no prior chemo for advanced disease) - You have responded to or have stable disease after starting FOLFIRINOX - Your general health is adequate for continued chemotherapy **You may NOT be eligible if...** - You have received prior chemotherapy for advanced pancreatic cancer - Your disease has progressed on FOLFIRINOX - Your overall health is too poor to continue chemotherapy - You have significant organ dysfunction (liver, kidney, bone marrow) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOxaliplatin

85 mg/sqm iv over 2 hours day 1

DRUGIrinotecan (CPT-11)

150 mg/sqm iv over 60 minutes day 1

DRUGLeucovorin

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

DRUG5-FU (5-fluorouracil)

2400 mg/sqm 46-hours infusion

DRUGgemcitabine

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

DRUGNab-paclitaxel

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

Locations(28)

Centro Di Riferimento Oncologico Di Aviano

Aviano, Italy, Italy

University Hospital Consorziale Policlinico

Bari, Italy, Italy

Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

Brescia, Italy, Italy

ASST Ospedale Maggiore di Crema

Crema, Italy, Italy

Azienda Socio Sanitaria Territoriale Di Cremona

Cremona, Italy, Italy

Careggi University Hospital

Florence, Italy, Italy

IRCCS Ospedale Policlinico San Martino

Genoa, Italy, Italy

Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.

Meldola, Italy, Italy

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

Milan, Italy, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Italy, Italy

Istituto Europeo Di Oncologia S.r.l.

Milan, Italy, Italy

ASST Grande Ospedale Metropolitano Niguarda

Milan, Italy, Italy

Humanitas Istituto Clinico Catanese S.p.A.

Misterbianco, Italy, Italy

Azienda Sanitaria Locale Napoli 1 Centro

Naples, Italy, Italy

Azienda Ospedaliero-Universitaria Maggiore Della Carità

Novara, Italy, Italy

Istituto Oncologico Veneto

Padova, Italy, Italy

Azienda Ospedaliero Universitaria Parma

Parma, Italy, Italy

Fondazione IRCCS Policlinico San Matteo

Pavia, Italy, Italy

Azienda Sanitaria Territoriale Di Pesaro E Urbino

Pesaro, Italy, Italy

Azienda Ospedaliero Universitaria Pisana

Pisa, Italy, Italy

Azienda Sanitaria Locale Della Provincia Di Biella

Ponderano, Italy, Italy

Azienda USL Toscana Centro

Prato, Italy, Italy

Azienda Unita Sanitaria Locale Della Romagna

Ravenna, Italy, Italy

I.F.O. Istituti Fisioterapici Ospitalieri

Rome, Italy, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Italy, Italy

Humanitas Mirasole S.p.A.

Rozzano, Italy, Italy

Pia Fondazione Di Culto E Religione Cardinale Giovanni Panico

Tricase, Italy, Italy

Azienda Sanitaria Universitaria Friuli Centrale

Udine, Italy, Italy

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