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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,100
* 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.
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.
Time frame: 3 years
OS will be defined as the time from date of randomisation to date of death by any cause, with living patients censored at date last known to be alive
Time frame: 3 years
Toxicity, graded according to the NCI-CTG Expanded Common Toxicity Criteria
Time frame: 3 years
Adverse events
Time frame: 3 years
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ASL 6 - Fabriano
Fabriano, Ancona, Italy
Ospedale Civile di Senigallia
Senigallia, Ancona, Italy
dell'Azienda Ospedaliero-Universitaria Ospedali Riuniti Umberto I
Torrette Di Ancona, Ancona, Italy
Ospedale. S. Donato
Arezzo, Arezzo, Italy
Presidio Ospedaliero di Ariano Irpino
Ariano Irpino, Avellino, Italy
A.O. "G. Rummo"
Benevento, Benevento, Italy
Ospedali "Riuniti"
Bergamo, Bergamo, Italy
A.O. "Ospedale Treviglio-Caravaggio"
Treviglio, Bergamo, Italy
Ospedale degli Infermi di Biella
Biella, Biella, Italy
Ospedale Maggiore-Bellaria
Bologna, Bologna, Italy
...and 91 more locations