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:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2025-12-24 @ 6:47 PM
NCT ID:
NCT02459457
Eligibility Criteria:
Inclusion criteria
To be eligible for this study, patient must fulfill all of the following criteria:
1. Histologically confirmed esophageal squamous cell carcinoma
2. Clinical stages II, III or IVa based on the 6th UICC-TNM classification
3. No prior treatment of chemotherapy, radiotherapy or surgery against esophageal cancer, except for non-curative resection by EMR/ESD.
4. Aged 18-75 years
5. Adequate organ functions
1. White blood cell (WBC) ≥3×109⁄L
2. Absolute neutrophil counts (ANC) ≥1.5×109⁄L
3. Hemoglobin (Hb) ≥10g⁄dl
4. Platelet (Plt) ≥100×109⁄L
5. Total bilirubin \<1.5 upper limit of normal (ULN)
6. Aspartate transaminase (AST) ≤2.5 ULN
7. Alanine aminotransferase (ALT) ≤2.5 ULN
8. Creatinine ≤1.5 ULN
6. ECOG PS of 0-2
7. Life expectancy ≥3 months
8. Written informed consent
Exclusion criteria Patients fulfilling any of the following criteria are ineligible for this study.
1. Esophageal perforation or hematemesis
2. Synchronous or metachronous malignancies (except for cutaneous (non-melanomas) carcinoma, thyroid papillary carcinoma, phase I seminoma or cervical carcinoma in situ curatively treated and disease free for a minimum of 3 months)
3. Received thoracic, abdominal or craniocerebral surgery within 30 days
4. Enrolled in other clinical trials within 30 days
5. Unstable angina and/or congestive heart failure requiring hospitalization within 6 months
6. Severe psychiatric disease
7. Pregnancy, lactation or unwillingness to adopt contraception
8. Drug addiction
9. Acquired immune deficiency syndrome (AIDS) based upon current CDC definition
10. Patients with hearing impairment or sensory-motor neuropathy of WHO grade \> 1
11. History of radiotherapy in the planning area
12. Other ineligible conditions according to researchers
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02459457
Study Brief:
Protocol Section:
NCT02459457