Gemcitabine Plus Nab-paclitaxel as Switch Maintenance Versus Continuation of Modified FOLF
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
| Condition(s) | Pancreatic Adenocarcinoma Advanced or Metastatic |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion Criteria: * 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. * Availability of archival tumor sample (primary tumor or metastatic site) for biomarker analysis. * ECOG performance status of 0-1 (if age \< 70 years). If age ≥70 years, ECOG PS must be 0. * E |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Gruppo Oncologico del Nord-Ovest |
| Locations | Aviano, Italy, Italy; Bari, Italy, Italy; Brescia, Italy, Italy; Crema, Italy, Italy; Cremona, Italy, Italy; Florence, Italy, Italy (+22 more sites) |
| Start date | 2025-03-27 |
| NCT ID | NCT06897644 |
| Official listing | https://clinicaltrials.gov/study/NCT06897644 |