Actively Recruiting
Gemcitabine Plus Nab-paclitaxel as Switch Maintenance Versus Continuation of Modified FOLFIRINOX as 1st Line Chemotherapy in Patients With Advanced Pancreatic Cancer.
Led by Gruppo Oncologico del Nord-Ovest · Updated on 2025-05-25
340
Participants Needed
28
Research Sites
248 weeks
Total Duration
On this page
Sponsors
G
Gruppo Oncologico del Nord-Ovest
Lead Sponsor
R
Rising Tide Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Gemcitabine Plus Nab-paclitaxel as Switch Maintenance Versus Continuation of Modified FOLFIRINOX as 1st Line Chemotherapy in Patients With Advanced Pancreatic Cancer.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to provide written informed consent and comply with the study
- Age 18 years or older
- Histologically or cytologically confirmed unresectable locally advanced or metastatic pancreatic adenocarcinoma eligible for first-line treatment
- Measurable or non-measurable disease assessed by CT or MRI according to RECIST 1.1
- Availability of archival tumor sample for biomarker analysis
- ECOG performance status 0-1 if under 70 years old; 0 if 70 years or older
- Estimated life expectancy over 3 months
- Adequate blood counts: ANC ≥ 1.5 × 10^9/L, platelets ≥ 100 × 10^9/L, hemoglobin ≥ 9 g/dL
- Adequate liver function: total bilirubin ≤ 1.5 × ULN and < 2 mg/dL, stable AST/ALT levels within defined limits
- Adequate kidney function: serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL/min
- Adequate blood clotting function: INR ≤ 1.5, PTT ≤ 5 seconds above ULN unless on anticoagulation
- No complete deficiency of DPYD enzyme based on gene testing
- Women of childbearing potential must agree to abstinence or use highly effective contraception during and 7 months after treatment
- Negative pregnancy test in premenopausal women within 7 days before treatment
- Men must agree to abstinence or use highly effective contraception during and 7 months after treatment
- Agreement not to donate eggs or sperm during and 7 months after treatment
You will not qualify if you...
- Pancreatic neuroendocrine, acinar, squamous/adenosquamous, or islet cell tumors
- Previous or current systemic therapy for advanced pancreatic adenocarcinoma, except prior neoadjuvant or perioperative therapy more than 9 months before and without progression
- Major surgery or radiation therapy within 4 weeks before randomization, except palliative bone radiotherapy more than 2 weeks before
- Known allergy or hypersensitivity to study drugs or their components
- Unresolved toxicity grade 2 or higher from prior treatments, excluding anemia or hair loss
- Symptomatic or untreated central nervous system metastases or requiring increasing corticosteroids
- Other active malignancies progressing or needing treatment, or history of other cancer within 2 years except certain skin or cervical cancers
- Active uncontrolled hepatitis B or C, though past or controlled infections allowed
- Active infections requiring systemic antibiotics or antifungals within 2 weeks prior to enrollment
- Uncontrolled HIV infection; controlled HIV with adequate CD4 count and undetectable viral load allowed
- Pregnant or breastfeeding or planning pregnancy within 7 months after treatment
- Severe or uncontrolled heart disease including recent heart attack or significant arrhythmia
- Psychiatric disorders preventing informed consent
- Serious medical conditions that would impair participation as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 28 locations
1
Centro Di Riferimento Oncologico Di Aviano
Aviano, Italy, Italy, 33081
Actively Recruiting
2
University Hospital Consorziale Policlinico
Bari, Italy, Italy, 70124
Not Yet Recruiting
3
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Brescia, Italy, Italy, 25123
Not Yet Recruiting
4
ASST Ospedale Maggiore di Crema
Crema, Italy, Italy, 26013
Actively Recruiting
5
Azienda Socio Sanitaria Territoriale Di Cremona
Cremona, Italy, Italy, 26100
Not Yet Recruiting
6
Careggi University Hospital
Florence, Italy, Italy, 50134
Not Yet Recruiting
7
IRCCS Ospedale Policlinico San Martino
Genoa, Italy, Italy, 16132
Not Yet Recruiting
8
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Meldola, Italy, Italy, 47014
Actively Recruiting
9
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan, Italy, Italy, 20122
Not Yet Recruiting
10
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy, Italy, 20133
Not Yet Recruiting
11
Istituto Europeo Di Oncologia S.r.l.
Milan, Italy, Italy, 20141
Not Yet Recruiting
12
ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy, Italy, 20162
Actively Recruiting
13
Humanitas Istituto Clinico Catanese S.p.A.
Misterbianco, Italy, Italy, 95045
Not Yet Recruiting
14
Azienda Sanitaria Locale Napoli 1 Centro
Naples, Italy, Italy, 80147
Not Yet Recruiting
15
Azienda Ospedaliero-Universitaria Maggiore Della Carità
Novara, Italy, Italy, 28100
Not Yet Recruiting
16
Istituto Oncologico Veneto
Padova, Italy, Italy, 35128
Actively Recruiting
17
Azienda Ospedaliero Universitaria Parma
Parma, Italy, Italy, 43126
Not Yet Recruiting
18
Fondazione IRCCS Policlinico San Matteo
Pavia, Italy, Italy, 27100
Not Yet Recruiting
19
Azienda Sanitaria Territoriale Di Pesaro E Urbino
Pesaro, Italy, Italy, 61122
Not Yet Recruiting
20
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy, Italy, 56126
Actively Recruiting
21
Azienda Sanitaria Locale Della Provincia Di Biella
Ponderano, Italy, Italy, 13875
Actively Recruiting
22
Azienda USL Toscana Centro
Prato, Italy, Italy, 59100
Actively Recruiting
23
Azienda Unita Sanitaria Locale Della Romagna
Ravenna, Italy, Italy, 48121
Actively Recruiting
24
I.F.O. Istituti Fisioterapici Ospitalieri
Rome, Italy, Italy, 00144
Not Yet Recruiting
25
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Italy, Italy, 00168
Not Yet Recruiting
26
Humanitas Mirasole S.p.A.
Rozzano, Italy, Italy, 20089
Not Yet Recruiting
27
Pia Fondazione Di Culto E Religione Cardinale Giovanni Panico
Tricase, Italy, Italy, 73039
Not Yet Recruiting
28
Azienda Sanitaria Universitaria Friuli Centrale
Udine, Italy, Italy, 33100
Not Yet Recruiting
Research Team
M
Monica Niger, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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