Randomized Multicenter Phase II Trial of Capecitabine Versus S-1 as First-line Treatment in Elderly Patients With Advanced or Recurrent Unresectable Gastric Cancer
Inclusion Criteria:
- Pathologically proven gastric or gastroesophageal junction adenocarcinoma
- Metastatic or recurrent unresectable disease
- Measurable lesions (according to Response Evaluation Criteria in Solid Tumors
[RECIST])
- Age: 65-85 years old
- Performance status: Eastern Cooperative Oncology Group (ECOG) 0-2
- Adequate bone marrow function: absolute neutrophile counts(ANC) ≥ 1,500/ul, platelet
count ≥ 100,000/ul, hemoglobin ≥ 9 g/dl)
- Adequate renal function (serum creatinine≤ 1.5)
- Adequate liver function (serum bilirubin ≤ 2 x upper limits of normal [UNL],
aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3 x UNL)
- No prior chemotherapy (but adjuvant chemotherapy completed at least 1 year prior to
study treatment is allowed with the exception of capecitabine or S-1) Written
informed consent was signed by the patient
Exclusion Criteria:
- Previous palliative chemotherapy
- Known allergy to study drugs
- CNS metastasis
- Significant medical comorbidities
- Active ongoing infection which antibiotic treatment is needed.
- Previous ( within 5 years) history of other malignancy except cured non-malignant
skin cancer and uterine cervical cancer in situ.