Open Label, Randomised, Multicenter Phase III Study of Adjuvant Chemotherapy in Radically Resected Adenocarcinoma of the Stomach or Gastroesophageal Junction: Comparison of a Sequential Treatment (CPT-11+5-FU/LV --> TXT+CDDP) Versus a 5-FU/LV Regimen
Open label, randomised, multicenter, superiority study for efficacy. Patients with
histologically proven adenocarcinoma of the stomach or gastroesophageal junction without
gross or microscopic evidence of residual disease after surgery with curative intent and
fulfilling all the inclusion/exclusion criteria are eligible for this study.
Allocation to treatment will be done centrally using a randomisation scheme and will be
stratified by center and nodal involvement (N- vs. N+). Access to random system will be
allowed by phone or via web.
All included patients in both groups will received fixed period of 18 weeks of treatment
unless unacceptable toxicity or disease relapse during treatment. After cessation of
therapy, patients will have a follow-up period while not receiving further treatment. After
relapse further chemotherapy is left to the investigator's judgement. When the last patient
is randomised, follow-up will be truncated at the achievement of the required number of
Time to progression and time to death are the main study outcomes. During the course of the
trial, an independent Data and Safety Monitoring Board (DSMB) will advise the Steering
Committee on efficacy and/or safety aspects of the study.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression Free Survival will be defined as the time from date of randomisation to date of first appearance of local, regional or distant relapse, or death from any cause; patients alive without relapse will be censored at date last known to be alive.
Emilio Bajetta, MD
Istituto Nazionale Per lo Studio e la Cura dei Tumori Milano
Italy: The Italian Medicines Agency