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

ConditionPancreatic Adenocarcinoma Advanced or Metastatic
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorGruppo Oncologico del Nord-Ovest

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Patient able and willing to provide written informed consent and to comply with the study protocol.

Subjects must be ≥18 years.

Histologically or cytologically confirmed unresectable locally advanced or metastatic pancreatic adenocarcinoma eligible for treatment in the first-line setting.

Presence of measurable or non-measurable disease assessed by CT scan and/or MRI according to RECIST 1.1. Note: any lesion which has been subjected to percutaneous therapies or radiotherapy should not be considered measurable, unless the lesion has clearly progressed since the procedure.

Disqualifiers

Pancreatic neuroendocrine, acinar, squamous/adenosquamous, or islet tumors.

Previous or concurrent systemic (e.g. cytotoxic or targeted or other experimental drugs) therapy for advanced pancreatic adenocarcinoma.

Major surgery or radiation therapy performed within <4 weeks before randomization. Palliative radiotherapy to bone lesions is allowed if performed > 2 weeks prior to start of study treatment. Patients must have recovered from an effect from major surgery.

Known allergy or hypersensitivity to study drugs and/or their excipients.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

340 Participants
are divided into 2 treatment groups
Group A: ARM A - continuation of mFOLFIRINOXActive comparator 4 interventions
Group B: ARM B - switch maintenance with Gem-NabPExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Gruppo Oncologico del Nord-Ovest

Lead sponsor

Rising Tide Foundation

Collaborator

Source ClinicalTrials.gov
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