Preoperative Chemotherapy With Weekly Cisplatin, Epirubicin and Paclitaxel (Intensified PET) in Patients With Locally Gastric Cancer : a Phase II Proof-of-concept Study.
The IPEC-GC study is a proof-of-concept study evaluating the efficacy and feasibility of PET
regimen in 61 patients with lower oesophagus, oesophagus junction or gastric carcinoma.
Preoperative chemotherapy include eight weekly preoperative cycles of cisplatin (30mg/m2),
epirubicin (50 mg/m2) and paclitaxel (90 mg/m2)with a break of one week without chemotherapy
between cycle 4 and 5. Surgery is performed within 4-6 weeks after the end of the last cycle
of chemotherapy. Primary endpoint of this trial is the curative resection rate (=R0). R0
must be higher than the 79% achieved in previous published studies. Response rate,
histologic response rate (Becker score), progression-free survival, overall survival, impact
of complete response in survival and dose-density are secondary endpoints. For an ancillary
study, tumors (biopsies and operative specimens) and sera will be collected to identify
biomarkers correlated with treatment efficacy.
This study is carried out by the Besançon University Hospital and were approved by the
independent Est-II ethics committee and by the French National Authority for Health:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
curative resection rate
an expected average of 4 weeks after surgery
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)