A Randomized Phase II Trial of Capecitabine Plus Cisplatin (XP) Versus Capecitabine Plus Genexol (XG) as a First-line Treatment for Advanced or Recurrent Esophageal Squamous Cell Carcinoma
Inclusion Criteria
Inclusion Criteria
- Histologically confirmed metastatic, or recurrent esophageal squamous cell carcinoma
- Age > 18 years
- ECOG performance status 0 - 2
- At least one measurable lesion(s) by RECIST criteria
- Life expectancy ≥ 3 months
- No prior palliative chemotherapy
- Patients may have received prior adjuvant chemotherapy with 5-FU with cisplatin as
long as it has been 6months since completion of regimen.
- Adequate bone marrow function (≥ ANC 1,500/ul, ≥ platelet 100,000/ul, ≥ Hb 9.0 g/dl)
- Adequate renal function (≤ serum creatinine 1.5 mg/dl or CCr ≥ 50 ml/min)
- Adequate liver function (≤ serum bilirubin 1.5 mg/dl, ≤ AST/ALT x 3 UNL)
- Written informed consent
Exclusion Criteria:
- Other tumor type than squamous cell carcinoma
- CNS metastasis
- Contraindication to any drug contained in the chemotherapy regimen
- Previous adjuvant treatment with 5-FU, cisplstin, capecitabine or paclitaxel finished
less than 1 year6 months
- Evidence of serious gastrointestinal bleeding
- History of another malignancy within the last five years except cured
- basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix
- Clinically significant cardiac disease
- Serious pulmonary conditions/illness
- Serious metabolic disease such as severe non-compensated diabetes mellitus
- History of significant neurologic or psychiatric disorders
- Serious uncontrolled intercurrent infections, or other serious uncontrolled
concomitant disease
- Positive serology for the HIV
- Pregnancy, breast feeding patient