Phase
Condition
Stomach Cancer
Gastric Cancer
Digestive System Neoplasms
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients ≥ 18 years
histologically confirmed inoperable locally advanced, recurrent, or metastaticadenocarcinoma of the stomach or gastro-oesophageal junction;
ECOG (Eastern Cooperative Oncology Group) performance status 0-2;
adequate renal, hepatic, and hematologic function;
measurable or nonmeasurable disease according to the Response Evaluation Criteria inSolid Tumors (RECIST). Patients with intraoperatively confirmed intraperitonealmetastases but without detectable disease in radiological studies were also eligible
Exclusion
Exclusion Criteria:
HER2- positive tumors defined as either IHC 3+ or IHC 2+, the latter in combinationwith FISH+
previous chemotherapy for metastatic or locally advanced disease
surgery <3 weeks before the onset of the study treatment
congestive heart failure
significant dysphagia that would preclude oral administration of capecitabine
concurrent malignant disease, except for adequately treated tumors with highlikelihood of being cured (e.g. basal cell carcinoma of the skin, cervical cancer)
clinical evidence of brain metastases