Status:
UNKNOWN
Efficacy Comparison Study of Combination Regimens to Treat Advanced Esophageal Squamous Cell Carcinoma
Lead Sponsor:
Samsung Medical Center
Conditions:
First Line Chemotherapy
Capecitabine Plus Cisplatin Versus Capecitabine Plus Paclitaxel
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...
Detailed Description
1. Introduction and Study Rationale 1.1 Esophageal squamous cell carcinoma Esophageal cancer is the seventh most common cancer in Korea, with almost 400,000 new patients diagnosed annually worldwi...
Eligibility Criteria
Inclusion
- 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
- Patients may have received prior adjuvant chemotherapy with 5-FU with cisplatin as long as it has been 12 months since completion of regimen.
- No previous palliative chemotherapy
- Prior radiotherapy must be completed 4 weeks before study entry.
- Adequate bone marrow function (≥ ANC 1,500/ul, ≥ platelet 100,000/ul, ≥ Hemoglobin 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 upper normal limit)
- Written informed consent
Exclusion
- Other tumor types such as adenocarcinoma, small cell carcinoma
- Evidence of CNS metastasis
- Contraindication to any drug contained in the chemotherapy regimen
- Previous adjuvant treatment with 5-FU, cisplatin, capecitabine or paclitaxel finished less than 1 year
- 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 (e.g. severe non-compensated hypertension, non-compensated heart failure, dilated cardiomyopathy, and coronary heart disease with ST segment depression in ECG) or myocardial infarction within the last 6 months.
- Serious pulmonary conditions/illness (e.g. chronic lung disease with hypoxemia)
- 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
- Pregnant or lactating women
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2018
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT00816634
Start Date
October 1 2008
End Date
December 1 2018
Last Update
May 1 2017
Active Locations (1)
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1
Samsung Medical Center
Seoul, South Korea, 135-710