At a glance
ClinicalIndex Comparison Record- ✓Grade 3 neuroendocrine carcinoma or high grade MiNEN with Grade 3 poorly differentiated neuroendocrine carcinoma component ≥30% of gastro-entero-pancreatic or unknown primary
- ✓Poorly differentiated histology
- ✓Small cell, large cell, non-small cell, or non-typeable morphology
- ✓Metastatic disease
- ✕Grade 3 well differentiated neuroendocrine tumor per WHO 2017 classification
- ✕Severe renal impairment with creatinine clearance <30 mL/min by MDRD
- ✕Partial or complete DPD deficiency with uracilemia ≥16 ng/mL
- ✕Gilbert's syndrome
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Folfirinox Versus Platinum - Etoposide as First Line Chemotherapy for Metastatic Grade 3 Poorly Differentiated Neuroendocrine Carcinoma of Gastro Entero Pancreatic and Unknown Primary Associated With Molecular Profiling for Therapeutic Targets & Predictive Biomarkers Identification
In Brief
A Phase 2 clinical trial evaluating FOLFOXIRI Protocol and Cisplatin injection for Neuroendocrine Carcinoma. Currently recruiting, targeting 218 participants across 6 sites.
Signals
Detailed Summary
there is a need for improving chemotherapy regimen for metastatic G3 NEC of GEP and Unknown origin and this goal may be achieved through more "personalized" chemotherapy regimen.the hypothesis is that mFOLFIRINOX regimen could be a good candidate for challenging the platinum-etoposide regimen in patients with metastatic G3 NEC of GEP or unknown origin. Furthermore, in order to get insights in the putative predictive biomarkers of efficacy of these two regimens, an effort toward a precise molecular characterization of these tumors is required in order to be able to define which subgroup of G3 NEC needs to be treated by which chemotherapy regimen. The FOLFIRINEC trial is set up in order to try to answer these questions
Study Details
Timeline
Interventions
Platinum-Etoposide regimen will be administered once every 21 days. Treatment will be continued for 6 to 8 cycles or 24 weeks maximum. One cycle consists of 21 days (3 weeks) with injection on D1 of each cycle (D1=D22). Patients are eligible for repeated treatment cycles in the absence of disease progression and undue adverse events.
Cisplatin 100 mg/m2, IV infusion over 3 hours or Carboplatin AUC 5, IV infusion over 30 minutes on day 1 \[the dose of carboplatin will be determined for each cycle using the Calvert's formula (carboplatin dose (mg) = target AUC 5 x estimated glomerular filtration rate (eGFR, mL/min) + 25)\]; • Etoposide 100 mg/m² IV infusion over 1 hour on day 1,2 and 3