Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-25 @ 2:38 AM
NCT ID:
NCT00816634
Eligibility Criteria:
Inclusion Criteria:
1. Histologically confirmed metastatic, or recurrent esophageal squamous cell carcinoma
2. Age \> 18 years
3. ECOG performance status 0 - 2
4. At least one measurable lesion(s) by RECIST criteria
5. Life expectancy ≥ 3 months
6. Patients may have received prior adjuvant chemotherapy with 5-FU with cisplatin as long as it has been 12 months since completion of regimen.
7. No previous palliative chemotherapy
8. Prior radiotherapy must be completed 4 weeks before study entry.
9. Adequate bone marrow function (≥ ANC 1,500/ul, ≥ platelet 100,000/ul, ≥ Hemoglobin 9.0 g/dl)
10. Adequate renal function (≤ serum creatinine 1.5 mg/dl or CCr ≥ 50 ml/min)
11. Adequate liver function (≤ serum bilirubin 1.5 mg/dl, ≤ AST/ALT x 3 upper normal limit)
12. Written informed consent
Exclusion Criteria:
1. Other tumor types such as adenocarcinoma, small cell carcinoma
2. Evidence of CNS metastasis
3. Contraindication to any drug contained in the chemotherapy regimen
4. Previous adjuvant treatment with 5-FU, cisplatin, capecitabine or paclitaxel finished less than 1 year
5. Evidence of serious gastrointestinal bleeding
6. History of another malignancy within the last five years except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix
7. 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.
8. Serious pulmonary conditions/illness (e.g. chronic lung disease with hypoxemia)
9. Serious metabolic disease such as severe non-compensated diabetes mellitus
10. History of significant neurologic or psychiatric disorders
11. Serious uncontrolled intercurrent infections, or other serious uncontrolled concomitant disease
12. Positive serology for the HIV
13. Pregnant or lactating women
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00816634
Study Brief:
Protocol Section:
NCT00816634