patients with advanced/metastatic gastric cancer not operable HER-2 negative MedDRA version: 13.1 Level: HLT Classification code 10017812 Term: Gastric neoplasms malignant System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 13.1 Level: SOC Classification code 10029104 Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps) System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 13.1 Level: HLGT
Conditions
Sponsors
AZIENDA OSPEDALIERA SENESE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: - Patients with advanced or metastatic gastric cancer, not operable, at first diagnosis or relapsed after surgery, histologically confirmed, HER-2 negative - Age more than 18 years - Negative pregnancy test within 7 days of starting study treatment in pre-menopausal women - Written informed consent - ECOG performance status 0-3 - No prior chemotherapy or radiation therapy (allowed only if neoadjuvant or adjuvant therapy but without the use of ECF and DCF schedules) - Adequate hematological function: white blood cells >3500/mmc, neutrophils >1500/mmc, platelets >100000/mmc, hemoglobin >10 mg/dl - Adequate liver function: serum bilirubin = 1,5 x ULN; transaminases = 2,5 x ULN (in case liver metastases 90 ml/min - Adequate cardiac function - Not other relevant comorbidities - Life expectancy more than three months 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: Exclusion criteria: - Other neoplastic diseases (excepted for cutaneous basalioma) - Pregnant or lactating women - Fertile men or women not using adequate contraception - Organ transplantation - Serious infection disease - Clinically significant cardiovascular disease - Immunodepression (for viral infection or genetic diseases) - Known hypersensitivity to any of the drugs in the study - Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - rate of patients free from disease progression after 6 months from the treatment start;Secondary Objective: - response rate (RR) - time to progression (TTP) - overall survival (OS) - treatment toxicity - quality of life (QoL);Primary end point(s): - rate of patients free from disease progression after 6 months from the treatment start | — |
Countries
Italy
Outcome results
None listed