Chemotherapy For Metastatic Grade 3 Poorly Differentiated NEuroendocrine Carcinoma Of GastroEnteroPancreatic And Unknown Primary

PHASE2RecruitingINTERVENTIONAL
Enrollment

218

Participants

Timeline

Start Date

September 1, 2020

Primary Completion Date

September 30, 2029

Study Completion Date

September 30, 2029

Conditions
Neuroendocrine Carcinoma
Interventions
DRUG

FOLFOXIRI Protocol

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.

DRUG

Cisplatin injection

"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"

Trial Locations (6)

10003

RECRUITING

CH de Troyes, Troyes

14033

RECRUITING

Chu de Caen, Caen

21000

RECRUITING

Chu Dijon Bourgogne, Dijon

RECRUITING

Institut de Cancérologie de Bourgogne, Dijon

35403

RECRUITING

Centre Hospitalier de Saint Malo, St-Malo

87042

RECRUITING

Chu de Limoges - Dupuytren, Limoges

All Listed Sponsors
collaborator

National Cancer Institute, France

OTHER_GOV

lead

Centre Hospitalier Universitaire Dijon

OTHER