Patients with histologically confirmed, localized gastric adenocarcinoma, that is considered operable. The bulk of disease must be localized in the stomach. MedDRA version: 9.1 Level: SOC Classification code 10017947
Conditions
Interventions
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Cisplatin
Concentration unit: mg/m2 milligram(s)/square meter
Concentration type: equal
Concentration number: 60-
Pharmaceutical Form:
Sponsors
IST. DI RICERCHE FARMACOLOG. M. NEGRI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: age >18 years ECOG-PS 0-1 T3 or T4 carcinoma without lymphnode involvement (N0) and any T-stage with (N+) lymphnode involvement no distant metastases (M0) fitness to receive CHT and CHT-RTX no peripheral neuropathy greater than grade 1 absence of peritoneal carcinomatosis written informed consents (one for each trial) given before the randomization, according to ICH/GCP Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: adenocarcinoma of the gastro-esophageal junction previous CHT or RTX abnormal haematological, hepatic or renal functions, assessed within 7 days prior to randomization lymphnode metastases (biopsy proof, if possible) outside the loco-regional field, such as supraclavicular, mediastinal or para-aortic nodes positive peritoneal cytology clinical significant (i.e. active) cardiovascular disease for example cerebrovascular accidents (= 6 months), myocardial infarction (= 6 months), instable angina, New York Heart Association grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, or inability to take oral medication ITACA-S 2 – Chemotherapy and chemo-radiotherapy in operable gastric cancer Clinical Study Protocol Version 1.0, 25.05.2010 Page 7 of 101 prior or coexisting malignancy within the last 5 years, except curatively treated basal cell skin cancer or carcinoma in situ of the cervix uteri history or presence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or patients at high risk from treatment complications pregnancy or breast feeding. Women of childbearing potential and their parents must be willing to practice acceptable methods of birth control to prevent pregnancy presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and f-up schedule
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The study addresses two primary questions, according to its factorial design: to compare the efficacy in terms of OS of a peri-operative vs. a post-operative CHT treatment, irrespectively of the presence of a post-surgical CHT-RTX (Timing Study); to compare the efficacy in terms of l-RFS of a post-surgical CHT-RTX treatment vs. no other treatment, irrespectively of the timing of CHT (RTX Study);Secondary Objective: To compare: the efficacy in terms of DFS of a peri-operative vs. a post-operative CHT treatment, irrespectively of the presence of a post-surgical CHT-RTX (Timing Study); the efficacy in terms of OS of a post-surgical CHT-RTX treatment vs. no other treatment, irrespectively of the timing of CHT (RTX Study); To evaluate the compliance, tolerability and safety profile of each treatment combination.;Primary end point(s): The primary efficacy endpoint is OS, defined for each patient as the time from the date of randomization to the date of death from any cause. Patients not reported as having died at the end of the study will be censored at the date they were last known to be alive. | — |
Countries
Italy
Outcome results
None listed