Intergroup Trial of Adjuvant Chemotherapy in Adenocarcinoma of the Stomach (ITACA-S)
|Adenocarcinoma of the Stomach Adenocarcinoma of the Gastroesophageal Junction||Drug: Irinotecan, Leucovorin, 5-Fluorouracil, Docetaxel, Cisplatin Drug: Leucovorin, 5-Fluorouracil||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- 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 ]
|Study Start Date:||February 2005|
|Study Completion Date:||January 2013|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
Experimental: Sequential regimen
Sequential treatment with CPT-11 plus Fluorouracil (FU), folinic acid (LV) and Docetaxel (TXT) plus Cisplatin (CDDP)
Drug: Irinotecan, Leucovorin, 5-Fluorouracil, Docetaxel, Cisplatin
After 3 weeks from last infusion:
Active Comparator: De Gramont regimen
Fluorouracil (5-FU), folinic acid (LV)
Drug: Leucovorin, 5-Fluorouracil
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01640782
Show 101 Study Locations
|Principal Investigator:||Emilio Bajetta, MD||Istituto Nazionale Per lo Studio e la Cura dei Tumori Milano|