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.
PANThEON is a randomized, open-label, multicenter phase III trial of switch maintenance with gemcitabine plus nab-paclitaxel (ARM B) versus mFOLFIRINOX continuation (ARM A) in patients with unresectable LAD or mPDAC without disease progression following 3 months of induction mFOLFIRINOX triplet chemotherapy. The induction chemotherapy regimen will be mFOLFIRINOX as per standard of care. Treatment must be continued for up to a maximum of 14 weeks, corresponding to \~ 6 bi-weekly cycles. A minimum of 4 treatment cycles administered is necessary for the patient to be evaluable for randomization. Radiological tumor assessment will be performed before the start and after completion of induction chemotherapy. Patients with complete/partial response or stable disease (CR/PR/SD) or without evidence of progressive disease (PD) in case of non-measurable disease will be randomized in a 1:1 ratio. Stratification factors will be ECOG Performance status (PS, 0 vs 1) and disease extension (LAD vs metastatic with presence of liver metastases vs metastatic without presence of liver metastases).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
340
85 mg/sqm iv over 2 hours day 1
150 mg/sqm iv over 60 minutes day 1
Leucovorin 400 mg/sqm (racemic) or l-Leucovorin 200 mg/sqm over 2 hours day 1
2400 mg/sqm 46-hours infusion
1000 mg/sqm over 30 minutes on Days 1,8,15 of a 28-day cycles
125 mg/sqm over 30 minutes on Days 1,8,15 of a 28-day cycles
Centro Di Riferimento Oncologico Di Aviano
Aviano, Italy, Italy
RECRUITINGUniversity Hospital Consorziale Policlinico
Bari, Italy, Italy
NOT_YET_RECRUITINGAzienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Brescia, Italy, Italy
NOT_YET_RECRUITINGASST Ospedale Maggiore di Crema
Crema, Italy, Italy
Overall Survival (OS)
OS is defined as the time from randomization to the date of death due to any cause. For patients still alive at the time of analysis, the OS time will be censored on the last date the patients were known to be alive.
Time frame: from date of randomization to date of death (or last follow up for alive patients), assessed up to 48 months
Progression Free Survival (PFS)
PFS will be defined as the time from randomization until disease progression or death, whichever will occur first; for patients alive and without progression time will be censored at the last known follow-up.
Time frame: from randomization to disease progression or death from any cause, assessed up to 48 months
Time to Treatment Failure (TTF)
TTF will be defined as the time from randomization to discontinuation of treatment for any reason, including progressive disease, treatment toxicity and death; in the absence of treatment failure time will be censored at the last known follow-up.
Time frame: from randomization to discontinuation of treatment for any reason, including progressive disease, treatment toxicity and death, assessed up to 48 months
Objective Response Rate (ORR)
ORR is defined as the percentage of patients achieving a complete (CR) or partial (PR) response, according to RECIST 1.1 criteria
Time frame: up to 48 months
Disease Control Rate (DCR)
DCR is defined as the percentage of patients achieving a complete (CR) or partial (PR) response or a stable disease (SD), according to RECIST 1.1 criteria
Time frame: Up to approximately 48 months
Quality of life (QoL)
QoL will be estimated with EORTC QLQ-C30 and the modules PAN26, FA12, CAX24, COMU26 a will be performed with the EORTC QLQ INFO25, which is a valid self-reported instrument consisting of 25 questions. Communication between patients and professionals will be assessed with the EORT QLC COMU26.
Time frame: Up to approximately 48 months
Toxicity rate
Toxicity is defined as the percentage of patients experiencing a specific adverse event, according to National Cancer Institute Common Toxicity Criteria (version 5.0).
Time frame: Up to approximately 48 months
Proportion of patients not eligible to randomization
Proportion of patients not eligible to randomization is defined as patients who started induction treatment but result not eligible due to i) clinical deterioration or treatment toxicity, ii) withdraw consent or iii) disease progression documented as best response, iv) other causes
Time frame: Up to approximately 48 months
Subsequent treatment line frequency
Subsequent treatment line frequency is defined as the percentage of patients who undergo a systemic treatment (excluding locoregional treatments or surgical treatment of unresectable disease) after progression to first line in both arms
Time frame: Up to approximately 48 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Azienda Socio Sanitaria Territoriale Di Cremona
Cremona, Italy, Italy
NOT_YET_RECRUITINGCareggi University Hospital
Florence, Italy, Italy
NOT_YET_RECRUITINGIRCCS Ospedale Policlinico San Martino
Genoa, Italy, Italy
NOT_YET_RECRUITINGIstituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Meldola, Italy, Italy
RECRUITINGFondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan, Italy, Italy
NOT_YET_RECRUITINGFondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy, Italy
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