Oxaliplatin in Gastric Cancer
Stomach Neoplasms
About this trial
This is an interventional treatment trial for Stomach Neoplasms
Eligibility Criteria
Inclusion Criteria: ECOG performance status of 0-2. Histologically proven gastric or gastro-esophageal junction adenocarcinoma. At least unidimensional measurable disease. If a unique metastasis constitutes the only disease sign, it requires histological confirmation. First line locally unresectable or metastatic gastric cancer. Relapsing gastric cancer after local and/or systemic treatment with a post-surgical period of at least 4 weeks, a post-adjuvant or neoadjuvant chemoradiotherapy period of at least 6 months. Serum bilirubin < 2 mg/dl Serum creatinine < or = 2 mg/dl Hemoglobin > or = 10 g/dl Absolute neutrophil count > or = 2000/dl Platelet count >or = 100, 000/dl AST/ALT < or = 2.5 time-fold the institutional normal upper limit Alkaline phosphatase < or = 5 time-fold the institutional normal upper limit Imagenological evaluation of the patient at least 2 weeks prior to the drug infusion Laboratory tests at least 1 week prior to the first infusion Patient available for follow up and able to answer to the quality of life questionnaire Exclusion Criteria: Symptomatic sensorial peripheral neuropathy Uncontrolled concomitant disease Another malignant neoplastic disease diagnosed within the previous 5 years to the diagnosis of advanced or metastatic gastric cancer, with the exception of 'in situ' cervix carcinoma or non-melanoma skin cancer Concomitant antitumoral treatment Cerebral metastases Unstable heart disease, even though in treatment Myocardial infarction within the last 6 months Radiotherapy within the last 6 weeks, surgery within the last 4 weeks, or chemotherapy within the last 6 months. Pregnancy or nursing ( or women in reproductive life without adequate contraception) Significant neurological or psychiatric disorders.