Adjuvant Treatment of Gastric Cancer With Chemotherapy and Chemoradiotherapy (TRACE)

Feasibility Study of 2 Parallel Phases II Pre or Postgastrectomy in Patients With Gastric Cancer (FOLFIRI-radiotherapy Plus 5 Fluorouracil-surgery or Surgery-FOLFIRI-radiotherapy Plus 5 Fluorouracil)

Post-operative radio-chemotherapy decrease the recurrence risk of gastric cancer(N Engl J Med 2001). However the chemotherapy regimen (5 fluorouracil IV bolus) used was toxic and suboptimal. We propose to evaluate in adjuvant situation an active and well tolerate chemotherapy regimen (FOLFIRI)in patients with metastatic gastric cancer. During the radiotherapy we will use 5 FU continue infusion as previously reported. The global design of adjuvant treatment will be four FOLFIRI courses, radiotherapy (45 Gy)with 5FU IV continue then four FOLFIRI.

Inclusion Criteria:

• gastric adenocarcinoma histologically confirmed
• tumor T3 or N+ at the pretherapeutic staging (Scanner and endoscopic ultrasound)
• performance status WHO<2
• serum albumin >30 gr/l
• weight loss < 10% in the next 6 months
• signed informed consent form

Exclusion Criteria:

• metastatic disease
• prior abdominal radiotherapy