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 @ 11:48 PM
Ignite Modification Date:
2025-12-24 @ 11:48 PM
NCT ID:
NCT03381651
Eligibility Criteria:
Inclusion Criteria:
Age:18-70 years
Histologically verified squamous carcinoma of the thoracic esophagus.
Patients with performance status 0-1 according to the Eastern Cooperative Oncology Group (ECOG) scale at the pre CRT evaluation and judges to be fit for surgery at the pre and post CRT evaluations.
Tumors should be resectable or potentially resectable and without distant metastasis, as assessed before neoadjuvant CRT, including clinical stage T2-4N0M0 or T1-4N1M0 according to the 6th AJCC system.
Joined the study voluntarily and signed informed consent form
No surgical contraindications
No serious system dysfunction and immuno-deficiency, Adequate organ function including the following: Hemoglobin ≥10 g/dL, Neutrophils (ANC )≥1.5x109/L, platelet count ≥100x 109/L, TBIL\<1.5 x ULN, ALT and AST ≤ 2.5 x ULN, creatinine≤1.5 x ULN
Exclusion Criteria:
Cervical esophageal cancer (The upper end of the lesion is in the esophagus of the cervical segment).
Patients with biopsy (by endoscopic ultrasound, laparoscopy, or laparotomy) proven metastatic supraclavicular or celiac nodes are ineligible.
Invasion of the tracheobronchial tree or aorta
Tracheoesophageal fistula
Concurrent pregnancy or lactation
Severe diabetes mellitus with poor blood glucose control
History of a second malignancy
Patients being unable to undergo esophageal reconstruction with gastric tube, due to prior surgery.
Patients undergoing esophageal reconstruction with jejunum.
Patients have allergy reaction or contraindications to taxanes.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03381651
Study Brief:
Protocol Section:
NCT03381651