Intergroup Trial of Adjuvant Chemotherapy in Adenocarcinoma of the Stomach
Condition: Adenocarcinoma of the Stomach; Adenocarcinoma of the Gastroesophageal Junction
MeSH terms: Adenocarcinoma; Esophageal Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    

Detailed description: 
      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 events.

      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.
    

Intervention name(s): Irinotecan, Leucovorin, 5-Fluorouracil, Docetaxel, Cisplatin; Leucovorin, 5-Fluorouracil
Intervention type(s): Drug; Drug
Intervention description(s): Irinotecan (CPT-11) 180 mg/m2, given as 60 min. i.v. infusion on day 1 every 2 weeks followed by
Leucovorin (LV) 100 mg/m2, given as a 2h i.v. infusion on days 1 and 2 every 2 weeks followed by
5-Fluorouracil (5-FU) 400 mg/m2 given as bolus, and then 5-Fluorouracil (5-FU) 600 mg/m2 given as a 22h continuous infusion on days 1 and 2, every 2 weeks for 4 administrations.
After 3 weeks from last infusion:
Docetaxel (TXT) 75 mg/m2, given as a 1h i.v. infusion on day 1 followed by
Cisplatin (CDDP) 75 mg/m2, given as a 1h i.v. infusion on.day 1, every 3 weeks, for 3 cycles.; Leucovorin (LV) 100 mg/m2, given as a 2h i.v. infusion on days 1 and 2 every 2 weeks followed by
5-Fluorouracil (5-FU) 400 mg/m2 given as bolus, and then 5-Fluorouracil (5-FU) 600 mg/m2 given as a 22h continuous infusion on days 1 and 2, every 2 weeks for 9 administrations.
Intervention MeSH terms: Leucovorin; Docetaxel; Fluorouracil; Irinotecan; Levoleucovorin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adenocarcinoma of the stomach; adenocarcinoma of the gastroesophageal junction