Status:
COMPLETED
Phase II Trial of XP Versus XG in Advanced Esophageal Squamous Cell Carcinoma
Lead Sponsor:
Samsung Medical Center
Conditions:
Advanced or Recurrent Esophageal Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Until today, the 5-FU/cisplatin combination is the reference regimen with 30-45% response rates, which is most commonly used to treat patients with metastatic, recurrent or locally advanced, unresecta...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT01474642
Start Date
September 1 2008
End Date
May 1 2014
Last Update
December 29 2015
Active Locations (1)
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1
Samsung Medical Center
Seoul, South Korea