ITACA-S 2 (Intergroup Trial in Adjuvant Chemotherapy for Adenocarcinoma of the Stomach): comparison of the efficacy of a peri-operative versus a post-operative chemotherapy treatment in patients with operable gastric cancer and assessment of the benefit of a post-operative chemo-radiotherapy - ITACA-S 2
- Conditions
- Patients with histologically confirmed, localized gastric adenocarcinoma, that is considered operable. The bulk of disease must be localized in the stomach.MedDRA version: 9.1Level: SOCClassification code 10017947
- Registration Number
- EUCTR2010-021052-25-IT
- Lead Sponsor
- IST. DI RICERCHE FARMACOLOG. M. NEGRI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method