Observational Study of Perioperative Chemotherapy in Gastric Cancer
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Observational

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.
    

Detailed description: 
      Chile belongs to the countries with a high mortality rate due to gastric cancer, and this
      disease is the most frequent cause of cancer death in Chile. Despite of adequate surgery,
      survival rates are disappointing, with less than 60% of patients for all stages achieving to
      be alive at 5 years. This is due to the fact that frequently gastric cancer is diagnosed at
      an advanced stage. For locally advanced gastric cancer a multimodality treatment is
      recommended, with the alternatives of surgery followed by chemotherapy (asian approach),
      surgery followed by chemoradiation (US approach) and perioperative chemotherapy (european
      approach). These three strategies are valid standard treatment options and have shown to
      improve overall survival in stage IB to IVA gastric cancer.

      Perioperative chemotherapy administered pre- and postoperatively, has shown to downstage the
      tumor, increase curative resection, progression free and overall survival.

      For patients with potentially resectable gastric cancer staged T2 or higher or cN+, NCCN
      Guidelines recommend perioperative chemotherapy (category1). Chilean guidelines for gastric
      cancer state the alternative of perioperative chemotherapy, however this approach has not
      been used widely in public hospitals because lack of financial support.

      Some gastric cancers overexpress HER2, and this subset of patients benefit from targeted
      therapy at an advanced stage. The proportions of patients with these molecular
      characteristics vary widely depending of the geographic area. The chilean population has been
      investigated in small series, but the incidence of HER2 positive gastric cancer is not known.
      We therefore plan to measure HER2 expression in all participating patients.
    

Intervention name(s): epirubicin + cisplatin + capecitabine polychemotherapy
Intervention type(s): Drug
Intervention description(s): EPIRUBICIN (LKM)at a dose of 50 mg/m2 over 15 minutes is administered every 21 days.
CISPLATIN (LKM) at a dose of 60 mg/m2 over 4 hours is administered every 21 days. Patients must receive standardized hydration per protocol.
CAPECITABINE (Xeloda®) at a dose of 625 mg/m2 BID (i.e. 1250 mg/m2/day) 30 minutes after meals from day 1 to day 21 of every cycle of chemotherapy.
Antiemetic therapy:
Dexamethasone 8 mg IV and Ondansetron (LKM) 8 mg IV o Granisetron (Kytril®) prior to chemotherapy
Rescue Ondansetron (LKM) 8 mg IV will be given during 24-hour hospitalization in case of emesis
Symptomatic antiemetic therapy with thiethylperazine will be prescribed.
Loperamide will be prescribed in case of diarrhea.
Intervention MeSH terms: Capecitabine; Epirubicin
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Current diagnosis of T3-4 and/or N+ M0 (according to staging system of the American Joint
        Committee on Cancer 2002) resectable gastric cancer. The resectability has to be confirmed
        by a surgical oncologist and/or Oncological Committee.
      
Keywords: gastric cancer; combination chemotherapy; HER-2 gene; quality of life