Observational Study of Perioperative Chemotherapy in Gastric Cancer

• Status: Completed
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess the efficacy and toxicity of perioperative chemotherapy with Epirubicin + Cisplatin + Capecitabine (ECX) in routine clinical practice in a network of public hospitals in Santiago, Chile.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Grupo Oncologico Cooperativo Chileno de Investigation
• Treatments: Capecitabine; Cisplatin; Epirubicin

Criteria

Inclusion Criteria:

• Histologically proven invasive carcinoma

• Age > 18 years.

• ECOG performance status 0 or 1.

• Hemoglobin > 9 g/dL

• Absolute neutrophil count > 1.5 x 109/L

• Platelet count > 100 x 109/L

• Creatinine < 1.5 ULN

• Creatinine clearance > 60 mL/min

• Serum bilirubin < 1.5 x ULN

• AST < 2.5 x ULN

• Women of child bearing potential: must agree to use an effective contraceptive method.

• Signed informed consent.

Exclusion Criteria:

• ECOG > 2.

• Pre-existing diarrhea uncontrolled with supportive care.

• Inability to swallow Xeloda tablets.

• History of mild-to-moderate renal insufficiency (creatinine clearance < 45 mL/min).

• Signs or symptoms of clinically significant hepatic dysfunction (bilirubin > 1.5 ULN, FA > 2.5 ULN, albumin < 2,5 g/dL).

• Significant cardiac dysfunction (LVEF < LLN)

• Presence of distant metastasis, including clinical signs of peritoneal carcinomatosis

• Symptomatic gastric retention or severe dysphagia with a caloric intake of < 1500 kcal/day

• Histology of lymphoma, GIST or neuroendocrine tumor

• Pregnant or breast-feeding women. Female patients must be postmenopausal, surgically sterile or they must agree to use an effective method of contraception.

• Any medical conditions that, in the investigator's opinion, would impose excessive risk to the patient. Examples of such conditions include congestive heart failure of Class III or IV of the NYHA classification, infection requiring parental or oral treatment, any altered mental status or any psychiatric condition that would interfere with the understanding of the informed consent.