Actively Recruiting
Chemotherapy For Metastatic Grade 3 Poorly Differentiated NEuroendocrine Carcinoma Of GastroEnteroPancreatic And Unknown Primary
Led by Centre Hospitalier Universitaire Dijon · Updated on 2025-09-30
218
Participants Needed
6
Research Sites
469 weeks
Total Duration
On this page
Sponsors
C
Centre Hospitalier Universitaire Dijon
Lead Sponsor
N
National Cancer Institute, France
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Chemotherapy For Metastatic Grade 3 Poorly Differentiated NEuroendocrine Carcinoma Of GastroEnteroPancreatic And Unknown Primary
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Grade 3 neuroendocrine carcinoma or high grade MiNEN with at least 30% poorly differentiated neuroendocrine carcinoma component of gastro-entero-pancreatic or unknown primary origin
- Poorly differentiated tumor type including small cell, large cell, non-small cell, or non-typeable
- Metastatic disease present
- No prior therapy for metastatic disease; no prior use of carboplatin, oxaliplatin, cisplatin, etoposide, irinotecan, or 5-fluorouracil
- At least one measurable lesion assessed by CT scan or MRI according to RECIST 1.1 guidelines
- Available tumor tissue block for analysis
- Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L, platelet count ≥ 100 x 10^9/L, and hemoglobin > 8 g/dL
- Total bilirubin ≤ 1.5 times normal, AST ≤ 2.5 times normal, ALT ≤ 2.5 times normal or AST/ALT ≤ 5 times normal if liver metastases present
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
- Signed informed consent and ability to comply with study requirements
- Women of childbearing potential and men with partners of childbearing potential agree to use effective contraception during the study and for 15 months after last dose
- Enrolled in social security system
You will not qualify if you...
- Grade 3 well differentiated neuroendocrine tumor by WHO 2017 classification
- Severe kidney impairment with creatinine clearance less than 30 mL/min
- Partial or complete deficiency of Dihydropyrimidine Dehydrogenase (DPD) enzyme
- Gilbert's syndrome
- Existing permanent neuropathy grade 2 or higher
- Previous chemotherapy or targeted therapy
- Brain metastases unless asymptomatic or stable under corticosteroids for 2 weeks; radiation required if symptomatic
- Use of sorivudine or similar drugs that inhibit DPD enzyme
- Treatment with St John's Wort
- Pregnant or breastfeeding women
- Active or untreated infections with HIV, hepatitis B, or hepatitis C
- History of prior malignancy except certain cured cancers with no disease for 3 years
- Uncontrolled acute or chronic diseases posing excess risk for study participation
- Live vaccinations within 30 days before starting study drugs
- Under guardianship or deprived of freedom
- Prolonged QT/QTc interval above specified limits
- Low potassium, magnesium, or calcium levels
- Known allergy to study chemotherapy agents or their ingredients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Chu de Caen
Caen, France, 14033
Actively Recruiting
2
Chu Dijon Bourgogne
Dijon, France, 21000
Actively Recruiting
3
Institut de Cancérologie de Bourgogne
Dijon, France, 21000
Actively Recruiting
4
Chu de Limoges - Dupuytren
Limoges, France, 87042
Actively Recruiting
5
Centre Hospitalier de Saint Malo
St-Malo, France, 35403
Actively Recruiting
6
CH de Troyes
Troyes, France, 10003
Actively Recruiting
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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