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 • ClinicalTrials.gov ID: NCT06897644
Recruiting for Similar Conditions?
Sponsors are looking for patients like you. See if you qualify for compensated research studies.
Check Eligibility →Description
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.
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
Eligibility criteria
Conditions
Locations
- Centro Di Riferimento Oncologico Di Aviano — Aviano, Italy
- University Hospital Consorziale Policlinico — Bari, Italy
- Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia — Brescia, Italy
- ASST Ospedale Maggiore di Crema — Crema, Italy
- Azienda Socio Sanitaria Territoriale Di Cremona — Cremona, Italy
- Careggi University Hospital — Florence, Italy
- IRCCS Ospedale Policlinico San Martino — Genoa, Italy
- Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l. — Meldola, Italy
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico — Milan, Italy
- Fondazione IRCCS Istituto Nazionale dei Tumori — Milan, Italy
- Istituto Europeo Di Oncologia S.r.l. — Milan, Italy
- ASST Grande Ospedale Metropolitano Niguarda — Milan, Italy
- Humanitas Istituto Clinico Catanese S.p.A. — Misterbianco, Italy
- Azienda Sanitaria Locale Napoli 1 Centro — Naples, Italy
- Azienda Ospedaliero-Universitaria Maggiore Della Carità — Novara, Italy
- Istituto Oncologico Veneto — Padova, Italy
- Azienda Ospedaliero Universitaria Parma — Parma, Italy
- Fondazione IRCCS Policlinico San Matteo — Pavia, Italy
- Azienda Sanitaria Territoriale Di Pesaro E Urbino — Pesaro, Italy
- Azienda Ospedaliero Universitaria Pisana — Pisa, Italy
- Azienda Sanitaria Locale Della Provincia Di Biella — Ponderano, Italy
- Azienda USL Toscana Centro — Prato, Italy
- Azienda Unita Sanitaria Locale Della Romagna — Ravenna, Italy
- I.F.O. Istituti Fisioterapici Ospitalieri — Rome, Italy
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Rome, Italy
- Humanitas Mirasole S.p.A. — Rozzano, Italy
- Pia Fondazione Di Culto E Religione Cardinale Giovanni Panico — Tricase, Italy
- Azienda Sanitaria Universitaria Friuli Centrale — Udine, Italy
Partner with Nurenyx
Showcase your study to thousands of motivated patients matching your criteria.
Learn MoreOfficial Source
Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
View Official Record